meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
41
Latest Decision
1981-09-23

Clearances · page 33 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K812491 IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3 Dako Corp. CZW Class II 1981-09-23
K812494 IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO Dako Corp. DAD Class II 1981-09-23
K812486 IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL Dako Corp. DDB Class II 1981-09-23
K812488 IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA Dako Corp. CZP Class II 1981-09-23
K812495 IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA Dako Corp. DEW Class II 1981-09-23
K812496 IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM Dako Corp. DCF Class II 1981-09-23
K812487 IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM Dako Corp. DAO Class II 1981-09-23
K812489 IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG Dako Corp. DEW Class II 1981-09-23
K812490 IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4 Dako Corp. DBI Class II 1981-09-23
K812414 KALLESTAD 125I ANTISERUM TO HUMAN IGE Kallestad Laboratories, Inc. DHB Class II 1981-09-14
K812370 GUINEA PIG COMPLEMENT REGULAR Dutchland Laboratories, Inc. KTQ Class I 1981-09-08
K812369 GUINEA PIG COMPLEMENT VIRUS ANTIBODY Dutchland Laboratories, Inc. KTQ Class I 1981-09-08
K812328 SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT Scripps-Miles, Inc. DEW Class II 1981-09-08
K812314 CRITHIDNA ANTI-DNA TEST KIT Antibodies, Inc. DHN Class II 1981-09-01
K812253 GELMAN IG-FIX KIT Gelman Sciences, Inc. CZP Class II 1981-09-01
K812327 KAPPA & LAMBDA BENCE JONES CONTROLS Kallestad Laboratories, Inc. CZQ Class II 1981-09-01
K812194 IMMUNODIFFUSION BAND INTENSIFYING FLUID American Scientific Products JZS Class I 1981-08-31
K812076 ANTI-GM & ANTI-KM TYPING SERUMS Biotest-Serum-Institut DGH Class II 1981-08-12
K811261 ANTI-SKIN ANTIBODY TEST SYSTEM Zeus Scientific, Inc. DBL Class II 1981-08-12
K812056 SPECTRO FEIRITIN Ramco Laboratories, Inc. DBF Class II 1981-08-12
K811613 72 DETERMIN. SIZE RADIAL IMMUNOD. TEST Kent Laboratories, Inc. DDG Class II 1981-08-12
K810459 THREE LEVEL CONTROL SERA Bd Becton Dickinson Vacutainer Systems Preanalytic DHX Class II 1981-08-03
K810694 PHADEBAS IGG RAST TEST Pharmacia, Inc. DEW Class II 1981-07-23
K811880 LEECO FERRITIN-QUANT DIAG. TEST KIT Leeco Diagnostics, Inc. DBF Class II 1981-07-16
K811721 H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME Immulok, Inc. DFH Class II 1981-07-16
K811740 KALLESTAD'S ENDOPLATE FACTOR B TEST Kallestad Laboratories, Inc. JZH Class II 1981-07-16
K810871 LIGHTNING DIALYZER Clintox Laboratories, Inc. DHY Class I 1981-07-10
K811714 HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT Scripps-Miles, Inc. DHN Class II 1981-07-10
K811808 AUTOPAK-12 FERRITIN KIT Micromedic Systems DBF Class II 1981-07-10
K811804 FERRITIN RIA KIT Amersham Corp. DBF Class II 1981-07-10
K811559 VENTRE/SEP IGE RIA TEST SET Ventrex Laboratories, Inc. DGC Class II 1981-07-10
K811777 HELENA PLASMINOGEN QUIPLATE PROCEDURE Helena Laboratories DDX Class I 1981-07-02
K811617 QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R. Kallestad Laboratories, Inc. DCK Class II 1981-06-25
K811445 KALLESTAD R QUANTIPLATE ALT. PATHWAY T. Kallestad Laboratories, Inc. DHL Class I 1981-06-24
K811545 KALLESTAD QUANTITOPE LOW LEVEL IGE REAG Kallestad Laboratories, Inc. DGC Class II 1981-06-24
K811433 SCRIPPSERA COMPLEMENT CONTROL SERA Scripps-Miles, Inc. DHL Class I 1981-06-16
K811375 BI-RA SLIDE TEST Biologics Intl., Inc. DHR Class II 1981-06-12
K811374 BI-CRP LATEX TEST Biologics Intl., Inc. DCN Class II 1981-06-12
K811394 CEA DESALTING DOLUMN SEPHADEX R Immuno-Diagnostic Laboratories DHX Class II 1981-06-12
K802913 TAN DEM* - IGE KIT Hybritech, Inc. DGC Class II 1981-05-29
K811124 AIM SYSTEM (FOR IGM) Icl Scientific DFT Class II 1981-05-08
K811126 AIM SYSTEM (FOR IGG) Icl Scientific DEW Class II 1981-05-08
K811125 AIM SYSTEM (FOR IGA) Icl Scientific CZP Class II 1981-05-08
K810984 ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST Immuno-Products Industries DBM Class II 1981-05-01
K810982 ANTITHYROID ANTIBODY IMMUNOFLUORESCENT Immuno-Products Industries JZO Class II 1981-05-01
K810983 ANTISMOOTH MUSCLE ANTIBODY TEST SYS Immuno-Products Industries DBE Class II 1981-05-01
K810985 ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT Immuno-Products Industries DHN Class II 1981-05-01
K810981 ANTI NDNA IMMUNOFLOURESCENT TEST SYS Immuno-Products Industries DHC Class II 1981-04-29
K811022 ANA TEST KIT Immuno-Diagnostic Products, Inc. DHN Class II 1981-04-23
K810810 AMICON ULTRAFILTRATION MEMBRANES CMII Amicon, Inc. DHX Class II 1981-04-17
K810863 KALLESTAD HEP-2 CELL LINE SUBSTRATE Kallestad Laboratories, Inc. DBM Class II 1981-04-14
K810501 SCRIPPSYSTEM C3 RID KIT Scripps-Miles, Inc. CZW Class II 1981-04-08
K810502 SCRIPPSYSTEM C4 RID KIT Scripps-Miles, Inc. DBI Class II 1981-04-08
K810862 CRP SLIDE Syn-Kit, Inc. DCN Class II 1981-04-08
K810799 QUANTIMUNE FERRITIN IRMA Bio-Rad JMG Class II 1981-04-03
K810625 HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- Serono Laboratories, Inc. DHI Class I 1981-03-27
K810507 PHADEZYM IGE PRIST TEST Pharmacia, Inc. DGC Class II 1981-03-20
K810404 RHEUMATOID FACTORS REFERENCE SERUM Calbiochem-Behring Corp. DHR Class II 1981-03-11
K810462 PHADEZYM RAST TEST Pharmacia, Inc. DHB Class II 1981-03-11
K810306 RHEUMATOID FACTOR REAGENT TEST KIT Beckman Instruments, Inc. DHR Class II 1981-03-11
K810301 CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST Immuno Concepts, Inc. DHN Class II 1981-02-25
K810141 SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT Scripps-Miles, Inc. DHR Class II 1981-02-09
K810056 IMMUNOLOGY CONTROL SERUM Icl Scientific DEW Class II 1981-02-09
K810081 SCRIPPSERA ANA REFERENCE CONTROL SERA Scripps-Miles, Inc. DHN Class II 1981-02-09
K810221 SCRIPPSERA THEUMATOID FACTOR REFER. CNTL Scripps-Miles, Inc. DHR Class II 1981-02-09
K810226 SLE ANTI-N-DNA LATEX TEST Icl Scientific DHC Class II 1981-02-09
K802299 K/K (ASMA/ANA) UNIVERSAL BIOPAK Bioware Products DHN Class II 1981-01-29
K803251 AIP SYSTEM-METHOD FOR IGM Icl Scientific DFT Class II 1981-01-26
K803272 AUTOMATED IMMUNOPRECIPITIN METHOD/ICG Icl Scientific DFZ Class II 1981-01-26
K803274 AUTOMATED IMMUNOPRECIPITIN METHOD/IGA Icl Scientific CZP Class II 1981-01-26
K803276 ANA-IFA TEST SYSTEM Immuno Concepts, Inc. DHN Class II 1981-01-26
K802527 TEST KIT FOR DETECTION OF ANTINUCLEAR Bartels & Stout, Inc. DHN Class II 1981-01-05
K802610 ALERT A,HDL-APOLIPOROTEIN A, TEST KIT Hyland Therapeutic Div., Travenol Laboratories DER Class II 1981-01-05
K802448 RA 80 EIKEN KIT DETERM. OF RHEUMATIC F. Syn-Kit, Inc. DHR Class II 1981-01-05
K802688 RHEUMATOID FACTOR TEST SYSTEMS Bd Becton Dickinson Vacutainer Systems Preanalytic DHR Class II 1980-12-18
K802556 PHADEBAS RAST TEST Pharmacia, Inc. DHB Class II 1980-12-02
K802308 T/K (ATA/AMA) UNIVERSAL BIOPAK Bioware Products DBM Class II 1980-12-01
K802196 GOAT ANTI-HUMAN COMPLEMENT C4 Protos Laboratories DBI Class II 1980-10-31
K802177 GOAT ANTI-HUMAN IGM Protos Laboratories DFT Class II 1980-10-31
K802257 GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC Protos Laboratories DEW Class II 1980-10-31
K802283 ANTISERA TO HUMAN FREE KAPPA CHAINS Kallestad Laboratories, Inc. DFH Class II 1980-10-23
K802404 ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE Ortho Diagnostics, Inc. DCF Class II 1980-10-23
K802284 ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. Kallestad Laboratories, Inc. CZQ Class II 1980-10-23
K801960 ANTI-DS/N-DNA TEST KIT Immuno-Diagnostic Products, Inc. DBL Class II 1980-10-10
K801961 RF-II TEST KIT Immuno-Diagnostic Products, Inc. DHR Class II 1980-10-10
K801949 BCM-302 COLLIMATING CONE & COMPENSATIN B C Medical , Ltd. JZW Class I 1980-10-03
K801909 LSA 290 ASSAY REAGENTS/NEPHELOMETRIC J.T. Baker Chemical Co. DEX Class I 1980-09-26
K792377 CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL Environmental Chemical Specialties DHX Class II 1980-09-26
K801306 CLINETICS PCA COLUMN Clinetics Corp. DHX Class II 1980-09-26
K801669 J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO J.T. Baker Chemical Co. DEM Class II 1980-09-16
K801662 J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. J.T. Baker Chemical Co. DEP Class II 1980-09-16
K801989 NORDICLAB FERRITIN IRMA TEST Nordiclab Intl. DBF Class II 1980-09-16
K801661 J.T. BAKER CERULOPLASMIN NEPHELOMETRIC J.T. Baker Chemical Co. DDB Class II 1980-09-16
K801676 FERRIZYME FERRITIN ENZYME IMMUNOASSAY Abbott Laboratories DBF Class II 1980-08-20
K801580 FERRITIN RIA KIT Diagnostic Products Corp. DBF Class II 1980-08-13
K801391 DISC 120 TRANSPORTER Travenol Laboratories, S.A. JZW Class I 1980-07-14
K801433 HAPTOGLOBIN NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. DAD Class II 1980-07-08
K801432 HEMOPEXIN NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. CZX Class II 1980-07-08
K801434 J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS J.T. Baker Chemical Co. DDG Class II 1980-07-08
K801282 J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA J.T. Baker Chemical Co. DFT Class II 1980-06-30

3,548 clearances in the Immunology panel. Data: openFDA.