meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
45
Latest Decision
1980-10-10

Clearances · page 39 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K801815 AUTOLET Ulster Scientific, Inc. JCA Class II 1980-10-10
K802117 FIBRI QUIK General Diagnostics GJA Class II 1980-09-26
K800857 HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH Helena Laboratories LCP Class II 1980-09-26
K802208 LEUKOCYTE VOL. ANALYSIS APPARATUS Coulter Electronics, Inc. GKL Class II 1980-09-17
K801545 ORTHO AUTOMATED CELL COUNTER Ortho Instruments GKL Class II 1980-09-09
K801932 HEP-TROL Helena Laboratories GGW Class II 1980-09-09
K801926 SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA Sigma Chemical Co. KQJ Class II 1980-09-09
K801357 MODIFIED BLOOD CELL COUNTING & LYSING Coulter Electronics, Inc. GIF Class I 1980-08-14
K801561 GLYCOSYLATED HEMOGLOBIN KIT Amersham Corp. LCP Class II 1980-08-12
K801346 NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA Nobel Scientific Industries, Inc. GIF Class I 1980-08-12
K801460 PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT Pacific Hemostasis GGW Class II 1980-07-28
K800925 VERIFY S PROD. #34141 General Diagnostics GGW Class II 1980-07-21
K801410 HEMOHLOBIN A2 CONTROL-LYOPHILIZED Isolab, Inc. JPD Class II 1980-07-21
K801386 PRE-DENT SYSTEM OR PRE-DENT II Pre-Dent System KSS Class I 1980-07-14
K801268 HEMOGLOBIN CONTROL LEVELS Bioscientific KHG Class II 1980-07-14
K800787 ANTIBODY TO VARICELLA-ZOSTER VIRUS Electro-Nucleonics Laboratories, Inc. GGW Class II 1980-07-14
K801265 WHITE BLOOD CELL COUNT CONTROL LEVELS Bioscientific JPK Class II 1980-07-14
K801425 RH CONTROL North American Biologicals, Inc. KSF Class II 1980-07-14
K801516 PRE-DENT SYSTEM MODIFIED Pre-Dent System KSS Class I 1980-07-14
K801267 RED BLOOD CELL COUNT & HEMATOCRIT CNTL Bioscientific JPK Class II 1980-07-14
K801422 SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. Sandare Chemical Co., Inc. LCP Class II 1980-07-08
K801289 LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT Leeco Diagnostics, Inc. LCP Class II 1980-06-30
K801155 TECHNICON H6000 HEMATOLOGY SYSTEM Technicon Instruments Corp. GKL Class II 1980-06-09
K800725 A-GENT QUANTICHROM THROMBIGEN I Abbott Laboratories GGW Class II 1980-06-04
K801143 VOLU-SOL URINARY DICHROME STAIN Volu Sol Medical Industries IDA Class I 1980-05-30
K801212 WRIGHTS RAPID STAIN Mcb Manufacturing Chemists, Inc. IAF Class I 1980-05-30
K800656 A-GENT QUANTICHROM THROMBIGEN-E Abbott Laboratories GGQ Class II 1980-05-30
K800826 FIBRINOGEN SCREEN Pacific Hemostasis KQJ Class II 1980-05-30
K800943 PENTEX BOVINE ALBUMIN 30% SOLUTION Miles Laboratories, Inc. KSG Class II 1980-05-08
K800938 TRI-CHECK Scientific Standards, Inc. JPK Class II 1980-05-08
K800699 FLO TEM (FLUID WARNER) Chroma Products, Inc. KZL Class II 1980-05-08
K800916 P1 BLOOD GROUP SUBSTANCE Travenol Laboratories, S.A. KSX Class II 1980-05-08
K800942 VOLU-SOL EOSIN Y STAIN Volu Sol Medical Industries HYB Class I 1980-05-08
K800926 THROMBOQUIK THROMBIN REAGENT PROD. #3551 General Diagnostics GJA Class II 1980-05-08
K800852 HEMESPEC CHECK SET Helena Laboratories KRZ Class II 1980-05-02
K800433 HELENA COLOCHECK Helena Laboratories KHE Class II 1980-05-02
K800853 A,SA2 LYOPHILIZED HEMO CONTROL Helena Laboratories JBD Class II 1980-04-29
K800856 A,FDA2 LYOPHILIZED HEMO CONTROL Helena Laboratories JBD Class II 1980-04-29
K800794 FAST HEMOGLOBIN CONTROL-LYOPHILIZED Isolab, Inc. LCP Class II 1980-04-29
K800854 A,A2 LYOPHILIZED HEMO CONTROL Helena Laboratories JBD Class II 1980-04-29
K800855 A,FSC LYOPHILIZED HEMO CONTROL Helena Laboratories JBD Class II 1980-04-29
K800780 SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS Sandare Chemical Co., Inc. JPK Class II 1980-04-24
K800736 PRE-DENT SYSTEM Pre-Dent System KSS Class I 1980-04-24
K800781 FETAL BOVINE SERUM Biolabs, Inc. KIS Class I 1980-04-21
K800667 MONITEMP BLOOD PACK TEMP. MONITOR Liquid Crystal Products, Inc. KSE Class II 1980-04-16
K800658 RST-SERIES CONTROL Gamma Biologicals, Inc. KSF Class II 1980-04-16
K800346 HEMOSAFE Med Lab Systems, Inc. GKL Class II 1980-04-16
K800361 HEMATO-CHEX Streck Laboratories, Inc. JPK Class II 1980-04-04
K800533 ADD OF RETICULOCYTE COUNT/CAPABILITIES Abbott Laboratories GKZ Class II 1980-04-04
K800059 COMPUR M-1000 MINI-PHOTOMETER Miles Laboratories, Inc. KHG Class II 1980-04-04
K800432 HELENA RISTOCETIN Helena Laboratories JOZ Class II 1980-03-25
K800180 VARIOUS REAGENTS FOR BLOOD CELL ANALYZER Laboratory Products, Inc. GIF Class I 1980-03-19
K800161 HEPCON/SYSTEM RC-10 Hemotec, Inc. JOX Class II 1980-03-19
K800310 ORTHO ANTISERA CONTROL Ortho Diagnostics, Inc. KSF Class II 1980-03-05
K800296 WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 Dade, Baxter Travenol Diagnostics, Inc. GGM Class II 1980-03-05
K800322 VOLU-SOL EA-50 STAIN Volu Sol Medical Industries HZJ Class I 1980-02-26
K792395 PHARMAFLEX CRYOGENIC BAG Pharmachem Corp. KSR Class II 1980-02-26
K800325 VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 Volu Sol Medical Industries HZJ Class I 1980-02-26
K800324 VOLU-SOL HARRIS HEMATOXYLIN Volu Sol Medical Industries HYK Class I 1980-02-22
K800323 VOLU-SOL ORANGE G-6 STAIN Volu Sol Medical Industries HZH Class I 1980-02-22
K800239 RH-HR NEGATIVE CONTROL REAGENT Gotham Biologics, Inc. KSF Class II 1980-02-21
K792606 WHOLE BLOOD PLATELET CONTROL NORMAL, Dade, Baxter Travenol Diagnostics, Inc. JPK Class II 1980-02-13
K800189 BOVINE ALBUMIN 22% & 30% SOLUTIONS Gotham Biologics, Inc. KSG Class II 1980-02-13
K800104 ROYCO MODEL 951 CELL MIXER Royco Instruments KSQ Class I 1980-02-06
K800121 TECHNICON C/90 SYSTEM Technicon Instruments Corp. GKZ Class II 1980-02-05
K800037 PLATELET RETENTION (ADHESION) COLUMNS Hemometrix JBZ Class II 1980-02-05
K800146 PLATELET AGGREGATION REAGENTS Pacific Hemostasis JOZ Class II 1980-02-05
K792537 COULTER COUNTER MODEL S PLUS Coulter Electronics, Inc. GKL Class II 1980-01-29
K792668 COULTER COUNTER-BLOOD CELL COUNTER Coulter Electronics, Inc. GKL Class II 1980-01-29
K792656 HELENA FACTOR XII DEFICIENT Helena Laboratories GGP Class II 1980-01-24
K792706 PARA-PAK(WHEATLEY'S TRICHROME STAIN) Meridian Diagnostics, Inc. HYW Class I 1980-01-24
K792655 HELENA COLOSCREEN Helena Laboratories KHE Class II 1980-01-24
K792582 POLY-LEC SYSTEM Gamma Biologicals, Inc. KSI Class II 1980-01-16
K792550 PONCEAU S STAIN SET Electrophoresis Corp. of America KQC Class I 1980-01-16
K792583 GAMMA ARACHIS HYPOGEA LECTIN Gamma Biologicals, Inc. KSI Class II 1980-01-16
K792563 THROMBOKINETIC FIBRINOGEN ASSAY Bio/Data Corp. KQJ Class II 1980-01-11
K792358 SANDARE CYANMETHEMOGLOBIN STANDARD Sandare Chemical Co., Inc. KRZ Class II 1979-12-31
K792503 SANDARE CYANMETHEMOGLOBIN REAGENT Sandare Chemical Co., Inc. KHG Class II 1979-12-31
K792475 HELENA FACTOR IX DEFICIENT SUBSTRATE Helena Laboratories GGP Class II 1979-12-31
K792467 PLATELET-CHEX FOR BLOOD CENTERS Streck Laboratories, Inc. JPK Class II 1979-12-31
K792476 HELENA FACTOR XI DEFICIENT SUBSTRATE Helena Laboratories GGP Class II 1979-12-31
K792511 HELENA FACTOR VII DEFICIENT SUB. PLASMA Helena Laboratories GGP Class II 1979-12-31
K792496 VOLU-SOL NMB RETICULOCYTE STAIN Volu Sol Medical Industries KQC Class I 1979-12-31
K792508 HELENA FACTOR X DEFICIENT SUBSTRATE Helena Laboratories GGP Class II 1979-12-31
K792507 HELENA FACTOR V DEFICIENT SUBSTRATE Helena Laboratories GGP Class II 1979-12-31
K792185 PIASMA SAFE Cry-O-Safe, Inc. KSR Class II 1979-12-28
K792336 HELENA FACTOR II DEFICIENT SUB. PLASMA Helena Laboratories GGP Class II 1979-12-27
K792483 STAINS, COUNTERSTAINS & GEN. PURPOSE Laboratory Products, Inc. ICL Class I 1979-12-18
K792549 FAT RED 7B STAIN SET Electrophoresis Corp. of America HYD Class I 1979-12-18
K792495 VOLU-SOL URINARY SEDIMENT STAIN Volu Sol Medical Industries ICF Class I 1979-12-18
K792552 AMIDO BLACK 10B STAIN Electrophoresis Corp. of America HZZ Class I 1979-12-18
K792497 VOLU-SOL STATIM STAIN Volu Sol Medical Industries IAF Class I 1979-12-18
K792546 FETAL CHECK Alta Diagnostics, Inc. KJR Class I 1979-12-18
K792335 HELENA FACTOR VIII DEFICIENT SUB. PLASMA Helena Laboratories GGP Class II 1979-12-04
K792209 SANDARE HEMOGLOBIN CONTROLS Sandare Chemical Co., Inc. JPK Class II 1979-12-04
K792310 NORM-TROL Helena Laboratories JPA Class II 1979-12-04
K792306 RH VIEWBOX Tekpro KSY Class I 1979-12-04
K792086 GLYCO-SPIN Applied Clinical Research Laboratories LCP Class II 1979-11-30
K791777 CORNING GLYCOSYLATED HEMOGLOBIN SET Corning Medical & Scientific LCP Class II 1979-11-13
K792026 WRIGHTS RAPID STAIN Mcb Manufacturing Chemists, Inc. IAF Class I 1979-11-13

4,197 clearances in the Hematology panel. Data: openFDA.