meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
34
Latest Decision
1987-08-24

Clearances · page 27 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K873137 IN VITRO 2.5X ROLLER BOTTLE In Vitro Scientific Products KJC Class I 1987-08-24
K873084 RPMI-1640 MEDIUM (HAT MODIFIED) NO. 200-2080 J R Scientific KIT Class I 1987-08-21
K873107 INSTANT HEMATOXYLIN Shandon, Inc. HYK Class I 1987-08-21
K872479 ASSERACHROM PROTEIN S TEST KIT American Bioproducts Co. GGP Class II 1987-08-21
K873085 WAYMOUTH 752/1 MEDIUM (MODIFIED) NO. 200-2085 J R Scientific KIT Class I 1987-08-21
K873023 RPMI-1640 W/L-GLUTAMINE AND W/O SODIUM BICARBONATE J R Scientific KIT Class I 1987-08-19
K873026 DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME) J R Scientific KIT Class I 1987-08-19
K873022 ISCOVE'S MODIFIED DULBECCO'S MEDIUM (IMDM) J R Scientific KIT Class I 1987-08-19
K873017 DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME) J R Scientific KIT Class I 1987-08-19
K873014 NUTRIENT MIXTURE F-10 (HAM) CAT. # 200-2060 J R Scientific KIT Class I 1987-08-19
K873015 NUTRIENT MIXTURE F-12 (HAM), CAT. #200-2065 J R Scientific KIT Class I 1987-08-19
K873018 DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME) J R Scientific KIT Class I 1987-08-19
K873020 MINIMUM ESSENTIAL MEDIUM EAGLE(MEM) CAT.#200-2041 J R Scientific KIT Class I 1987-08-19
K873025 MINIMUM ESSENTIAL MEDIUM EAGLE(MEM) CAT.#200-2115 J R Scientific KIT Class I 1987-08-19
K873016 MCCOY'S 5A MEDIUM (IWAKATA & GRACE MODIFICATION) J R Scientific KIT Class I 1987-08-19
K873013 MINIMUM ESSENTIAL MEDIUM EAGLE(MEM ALPHA MODIFICA) J R Scientific KIT Class I 1987-08-19
K873024 MEDIUM 199, CATALOG NO. 200-2030 J R Scientific KIT Class I 1987-08-19
K873028 MINIMUM ESSENTIAL MEDIUM EAGLE(MEM ALPHA MODIFICA) J R Scientific KIT Class I 1987-08-19
K873027 MINIMUM ESSENTIAL MEDIUM EAGLE (MEM)CAT. #200-2045 J R Scientific KIT Class I 1987-08-19
K873019 MINIMUM ESSENTIAL MEDIUM EAGLE(MEM), CAT.#200-2040 J R Scientific KIT Class I 1987-08-19
K873021 L-15 MEDIUM, CAT. #200-2020 J R Scientific KIT Class I 1987-08-19
K872918 GIT SERUM-FREE MEDIUM FOR CELL CULTURE Wako Chemicals USA, Inc. KIT Class I 1987-08-11
K872847 SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT Candace Lane Corp. KIS Class I 1987-08-10
K872844 THROMBOREL S Behring Diagnostics, Inc. GJS Class II 1987-08-06
K872761 CELL-DYN 610 HEMATOLOGY ANALYZER Abbott Diagnostics GKZ Class II 1987-08-06
K872195 DATA-FI DIMERTEST LATEX ASSAY American Dade DAP Class II 1987-08-06
K872217 THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT Pacific Hemostasis GHM Class II 1987-07-31
K872186 SULFURIC ACID 10% Remel Co. JTS Class I 1987-07-29
K872184 TB METHYLENE BLUE Remel Co. JTS Class I 1987-07-29
K872189 METHANOL, ABSOLUTE Remel Co. JTS Class I 1987-07-29
K872185 LIGHT GREEN Remel Co. JTS Class I 1987-07-29
K872187 TB KINYOUN CARBOLFUCHSIN Remel Co. JTS Class I 1987-07-29
K871679 FOCUS-GHB Awareness Technology, Inc. LCP Class II 1987-07-28
K872653 EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 Em Diagnostic Systems, Inc. KHG Class II 1987-07-23
K864579 MINOS AUTOMATIC CELL COUNTER Abx, Inc. GKZ Class II 1987-07-16
K872465 DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME) J R Scientific KIT Class I 1987-07-09
K872499 ANATECH HEMATOXYLIN-NORMAL STRENGTH Anatech, Ltd. HYJ Class I 1987-07-09
K872498 HARRIS HEMATOXYLIN Anatech, Ltd. HYK Class I 1987-07-09
K872500 ANATECH HEMATOXYLIN-EXTRA STRENGTH Anatech, Ltd. HYJ Class I 1987-07-09
K872377 CHROM-TROL Helena Laboratories JPA Class II 1987-07-09
K871388 MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER Bio-Rad LCP Class II 1987-07-06
K872360 DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET American Dade GHH Class II 1987-07-06
K871837 COULTER COUNTER MODEL S-PLUS STKR Coulter Electronics, Inc. GKZ Class II 1987-07-02
K871600 SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY. Toa Medical Electronics USA, Inc. GKZ Class II 1987-06-24
K872076 CORNING DISPOSABLE ROLLER BOTTLES Corning Medical & Scientific KJB Class I 1987-06-15
K872086 ACUSYST-JR Endotronics, Inc. KJH Class I 1987-06-15
K871318 Q.I.C. BLEEDING TIME DEVICE Helena Laboratories JCA Class II 1987-06-10
K870831 PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA International Technidyne Corp. JPA Class II 1987-06-01
K870451 SKIN GRAFT PRESERVATION MEDIUM (TISSUE) Bioclinical Laboratory Services, Inc. KIT Class I 1987-05-26
K871039 STACHROM PROTEIN C TEST KIT American Bioproducts Co. GGP Class II 1987-05-21
K871476 SILVER STAIN REAGENT SYSTEM Sigma Chemical Co. LEF Class I 1987-05-21
K862122 S-CAL HEMATOLOGY CALIBRATOR Coulter Electronics, Inc. KRY Class II 1987-05-20
K871671 URINOSCOPY FUNNEL Portable Medical Laboratories, Inc. GHO Class I 1987-05-20
K871606 SPOTTEST FLAGELLA STAIN Difco Laboratories, Inc. JTS Class I 1987-05-15
K871613 BUFFALO GREEN MONKEY KIDNEY CELLS Viromed Laboratories, Inc. KIR Class I 1987-05-13
K871545 NEW FUCHSIN SOLUTION Sigma Diagnostics, Inc. IDF Class I 1987-04-29
K871477 NEUTRAL RED Sigma Chemical Co. KFE Class I 1987-04-29
K871532 TOMTEC GRAM STAINER CRYSTAL VIOLET Remel Co. JTS Class I 1987-04-29
K871483 TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES Isratech Marketing Corp. KIZ Class I 1987-04-29
K871544 METHYL GREEN SOLUTION Sigma Diagnostics, Inc. HZA Class I 1987-04-29
K870210 CLEARVIEW CW-10 Clearview Instruments, Inc. GKR Class II 1987-04-28
K864643 GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT Pacific Hemostasis LCP Class II 1987-04-28
K871250 INTRA-ARTICULATED ARTHRO POWER SYSTEM Richard Wolf Medical Instruments Corp. KIT Class I 1987-04-27
K870771 PT HEPARIN ADSORBENT Probe-Tek, Inc. JPA Class II 1987-04-23
K870917 PROTEIN S CONTROL PLASMA American Bioproducts Co. GGP Class II 1987-04-23
K870685 COAGULATION CONTROL, LEVEL I U. S. Diagnostics, Inc. JPA Class II 1987-04-20
K870686 COAGULATION CONTROL, LEVEL II U. S. Diagnostics, Inc. JPA Class II 1987-04-20
K870596 PROTHROMBIN TIME TEST U. S. Diagnostics, Inc. GJS Class II 1987-04-20
K870687 COAGULATION CONTROL, LEVEL III U. S. Diagnostics, Inc. JPA Class II 1987-04-20
K871283 CYANMETHEMOGLOBIN STANDARD U. S. Diagnostics, Inc. KRZ Class II 1987-04-15
K870860 CHEMPRO 1000(TM) Arden Medical Systems, Inc. GKF Class II 1987-04-14
K871324 DU PONT STERICELL CELL CULTURE SYSTEM E.I. Dupont DE Nemours & Co., Inc. KJA Class I 1987-04-14
K871286 GRAM IODINE Remel Co. HYI Class I 1987-04-08
K870580 MLC NORMAL SERUM Rjo Biologicals, Inc. KIS Class I 1987-04-08
K871117 TB QUICK STAIN(TM) KIT Bd Becton Dickinson Vacutainer Systems Preanalytic ICJ Class I 1987-04-03
K871191 (DMF/F-12) HYBRI-MAX(TM) W/L-GLUTAMINE Sigma Chemical Co. KIT Class I 1987-04-03
K871033 RABBIT KIDNEY CULTURE CELLS (FIRST PASS) Microscan Div. Baxter Healthcare Corp. KIR Class I 1987-03-31
K870688 O.O2 M CALCIUM CHLORIDE SOLUTION U. S. Diagnostics, Inc. JPA Class II 1987-03-31
K870876 HL-1 SUPPLEMENT Ventrex Laboratories, Inc. KIT Class I 1987-03-31
K870603 SYSTEM 9000 AUTOMATED CELL COUNTER Baker Instructions Corp. GKL Class II 1987-03-31
K870938 FETAL BOVINE SERUM Hyclone Laboratories, Inc. KIS Class I 1987-03-31
K870498 ISCOVE MOD DULBECCO MED HYBRI-MAX, PRODUCT# I2510 Sigma Chemical Co. KIT Class I 1987-03-30
K870865 TISSUE CULTURE BAG American Fluoroseal Corp. KJA Class I 1987-03-30
K864701 VWF IMMUNOBLOT Ramco Laboratories, Inc. GGP Class II 1987-03-30
K870480 NCTC 135 MEDIUM HYBRI-MAX W/L-GLUTAMINE #N5138 Sigma Chemical Co. KIT Class I 1987-03-30
K870488 RPMI 1640 MEDIUM DEFI. MODIFICATION NO. R7130 Sigma Chemical Co. KIT Class I 1987-03-30
K870499 MCCOY 5A MED (MOD) SUUSPENSION CULTURE, M6523 Sigma Chemical Co. KIT Class I 1987-03-30
K870492 DULBECCO'S MODIFIED EAGLE MEDIUM BASE NO. D5030 Sigma Chemical Co. KIT Class I 1987-03-30
K870529 F-12 MEDIUM, COON'S MODIFICATION PRODUCT NO. F6636 Sigma Chemical Co. KIT Class I 1987-03-30
K870490 (DME) W/1000 MG GLUCOSE/L NO. D4655 Sigma Chemical Co. KIT Class I 1987-03-30
K870530 MEDIUM 199 WITH EARLE'S SALTS PRODUCT NO. M2520 Sigma Chemical Co. KIT Class I 1987-03-30
K870496 DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM) Sigma Chemical Co. KIT Class I 1987-03-30
K870482 (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 Sigma Chemical Co. KIP Class I 1987-03-30
K870485 LACTALBUMIN HYDROLYSATE (ELAH) NO. L3762 Sigma Chemical Co. KIT Class I 1987-03-30
K870988 PRICE'S ACID-FAST STAIN Devetec, Inc. JTS Class I 1987-03-30
K870487 H-Y MEDIUM (DME:NCTC109, 7:1 MIX.) HYBRI-MAX H9014 Sigma Chemical Co. KIT Class I 1987-03-30
K870481 (S-MEM) AUTO-MOD PRODUCT NO. M7272 Sigma Chemical Co. KIT Class I 1987-03-30
K870494 RPMI-1640 HYBRI-MAX PRODUCT NO. R8005 Sigma Chemical Co. KIT Class I 1987-03-30
K870483 WILLIAMS' MEDIUM E W/L-GLUTAMINE #W4125 Sigma Chemical Co. KIT Class I 1987-03-30
K870479 (DME) HYBRI-MAX W/L-GLUTAMINE PRODUCT NO. D6780 Sigma Chemical Co. KIT Class I 1987-03-30

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