Atlas FDA

JPK

192 FDA 510(k) clearances · Product code

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MSI HEMATOLOGY CONTROL + (K871067)Medical Specialties, Inc.1987-03-25
HEMATALL-C PLUS HEMATOLOGY CONTROLS (K863224)Fisher Scientific Co., LLC1986-10-29
FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR (K862318)Fisher Scientific Co., LLC1986-07-10
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II (K862186)Bio-Rad1986-07-01
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA (K860751)Bio/Data Corp.1986-03-18
PLATELET-TROL II (K854353)R&D Systems, Inc.1985-11-26
PARA CHECK (AKA EIGHT CHECK-C) (K852992)Streck Laboratories, Inc.1985-10-10
MSI-HB HEMOGLOBIN CONTROL (K853776)Medical Specialties, Inc.1985-09-19
CELL-DYN BRAND HEMATOLOGY REAGENTS (K852372)Abbott Diagnostics1985-09-03
QUICK-COUNT HEMATOLOGY CONTROLS (K851663)Seragen Diagnostics, Inc.1985-07-23
TRI-COUNT (K851375)Hematology Marketing Assoc.1985-07-12
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL (K850755)R&D Systems, Inc.1985-05-13
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH (K850250)Technicon Instruments Corp.1985-04-01
HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 (K844897)Medical Specialties Laboratories1985-03-22
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS (K844927)Bhp Diagnostix, Inc.1985-03-22
QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE (K844928)Bhp Diagnostix, Inc.1985-03-22
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG (K843805)Coulter Electronics, Inc.1984-12-17
TRI-COUNT LASER (K843485)Hematology Marketing Assoc.1984-12-12
COUNT-A-PART PLUS (K841809)Diagnostic Technology, Inc.1984-11-30
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE (K843962)R&D Systems, Inc.1984-11-01
RETIC-CHEX (K843093)Streck Laboratories, Inc.1984-10-23
DIA T1, T2 & T3 (K842286)Diatech, Inc.1984-09-11
TECHNICON TEST POINT ASSAYED HEMATOLOGY (K842109)Technicon Instruments Corp.1984-07-27
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH (K842440)Anco Medical Reagents & Assoc.1984-07-27
PARA-TEK (K841531)Streck Laboratories, Inc.1984-07-27
PARA 4 (K842017)Streck Laboratories, Inc.1984-06-26
ASSIGNED VALUE FOR MEAN PLATELET (K841239)Coulter Electronics, Inc.1984-05-02
PLT - 4 PLATELET (K840302)R&D Systems, Inc.1984-03-12
TRI-COUNT 10 (K834371)Hematology Marketing Assoc.1984-03-09
HC PLUS (K833563)Coulter Electronics, Inc.1984-01-03
MSI-HC HEMATOLOGY CONTROL (K834043)Medical Specialties, Inc.1984-01-03
TRI-COUNT 7 (K833130)Hematology Marketing Assoc.1983-10-20
TECHNICON H6000 SYSTEM CONTROL (K831704)Technicon Instruments Corp.1983-07-06
WHITE BLOOD CELL CONTROL (K830864)Control Diagnostics1983-06-15
PARA LASAR (K831094)Streck Laboratories, Inc.1983-06-08
HEMATALL-C PLUS HEMATOLOGY CONTROLS (K820731)Fisher Scientific Co., LLC1982-05-12
ORTHO* HEMATOLOGY CONTROL 8 NORMAL (K820400)Ortho Diagnostic Systems, Inc.1982-03-15
ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW (K820401)Orhto Diagnostic Systems, Inc.1982-03-15
HEMOTOLOGY QUALITY CONTROL MIXTURE (K812237)American Dade1981-09-09
HEMATOLOGY CONTROL (K812280)American Dade1981-09-09
VENTREX DATA REDUCTION & QUAL. CONTR. SY (K812357)Ventrex Laboratories, Inc.1981-09-01
HEMOTOLOGY QUALITY CONTROL MIXTURES (K810756)Scientific Standards, Inc.1981-06-30
THROMBO-TEST (X) (K801054)Medtro GmbH1981-03-13
ORTHO HEMOTOLOGY CONTROL-NORMAL (K803083)Ortho Instruments1980-12-31
ORTHO HEMATOLOGY CONTROL (K803073)Ortho Instruments1980-12-31
ORTHO HEMATOLOGY CONTROL ABNORMAL LOW (K803084)Ortho Instruments1980-12-31
CBC PLT-4 (K802265)R&D Systems, Inc.1980-11-12
PLT-4 SIZE-CHECK (K802267)R&D Systems, Inc.1980-11-12
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL (K802141)American Dade1980-10-10
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL (K802142)American Dade1980-10-10
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET (K802143)American Dade1980-10-10
WHITE BLOOD CELL COUNT CONTROL LEVELS (K801265)Bioscientific1980-07-14
RED BLOOD CELL COUNT & HEMATOCRIT CNTL (K801267)Bioscientific1980-07-14
TRI-CHECK (K800938)Scientific Standards, Inc.1980-05-08
SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS (K800780)Sandare Chemical Co., Inc.1980-04-24
HEMATO-CHEX (K800361)Streck Laboratories, Inc.1980-04-04
WHOLE BLOOD PLATELET CONTROL NORMAL, (K792606)Dade, Baxter Travenol Diagnostics, Inc.1980-02-13
PLATELET-CHEX FOR BLOOD CENTERS (K792467)Streck Laboratories, Inc.1979-12-31
SANDARE HEMOGLOBIN CONTROLS (K792209)Sandare Chemical Co., Inc.1979-12-04
FISHER DIAGNOSTICS HEMATOLOGY CONTROLS (K792055)Fisher Scientific Co., LLC1979-11-05
COUNTER-CHECK PLUS NORMAL, HIGH ABN. (K791772)Diagnostic Technology, Inc.1979-10-11
COUNTER-CHECK PLUS (K791750)Diagnostic Technology, Inc.1979-10-11
PARA-8 (K791228)Streck Laboratories, Inc.1979-08-03
PARA-7 (K791227)Streck Laboratories, Inc.1979-08-03
PLATELET-CHEX PLUS (K791226)Streck Laboratories, Inc.1979-08-03
HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL (K791030)Beckman Instruments, Inc.1979-06-22
COAGULATION ARP (K790826)Helena Laboratories1979-05-31
HEMOGLOBIN CONTROLS (K790457)Data Medical Associates, Inc.1979-04-04
HCP-7 (K790415)Bioscientific1979-04-04
HEMATROL S HEMATOLOGY CONTROLS (K790525)Fisher Scientific Co., LLC1979-04-03
BLOOD, HEMATOLOGY REFERENCE CONTROL (K781969)Coulter Electronics, Inc.1979-01-03
QUANTICEL HHR # L500 AND L501 (K781786)Bhp Diagnostix, Inc.1978-11-15
QUANTICEL HHR, L531 AND L532 (K781745)Bhp Diagnostix, Inc.1978-11-15
NORMAL HEMATOLOGY CONTROL UNASSAYED (K781572)Ortho Diagnostics, Inc.1978-10-17
ABNORMAL HEMATOLOGY CONTROL UNASSAYED (K781573)Ortho Diagnostics, Inc.1978-10-17
QUANTICEL-HRP (K781247)Bhp Diagnostix, Inc.1978-09-14
CONTROL, HEMATOLOGY, CH-60 (K781077)Dade, Baxter Travenol Diagnostics, Inc.1978-07-27
PLATELET CONTROL (K780980)Bhp Diagnostix, Inc.1978-07-27
ARANTROL (K780835)Aranco Diagnostic Laboratories, Inc.1978-06-22
PLATELET CONTROL (K780714)Bhp Diagnostix, Inc.1978-06-06
CELL-CHEX (K780140)Streck Laboratories, Inc.1978-03-27
HEMATOLOGY REFERENCE CONTROLS (K772195)R&D Systems, Inc.1978-02-03
HEMATOLOGY REFERENCE CONTROL (K771753)Coulter Electronics, Inc.1977-11-28
MNITROL HEMOTOL. REF. AND CONTROL (K770384)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-04-08
LATELET, CONTROL, NORMAL & ABNORMAL (K770386)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-03-21
PLATELET CONTROL, NORMAL & ABNORMAL (K770095)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-02-28
PLATELET-CHEX-HUMAN (K770020)Streck Laboratories, Inc.1977-02-16
PLATELET CONTROLS, NORMAL & ABNORMAL (K760549)Dade, Baxter Travenol Diagnostics, Inc.1976-10-08
4C ABNORMAL LOW-HIGH (8 X 6 M1) (K760682)Coulter Electronics, Inc.1976-10-08
BIOTROL-ABNORMAL (K760596)Boehringer Mannheim Corp.1976-10-08
BIOTROL-NORMAL (K760597)Boehringer Mannheim Corp.1976-10-08
HEMATOLOGY CONTROL (K760162)Biological Corp. of America1976-08-04
← Previous

Track JPK automatically

Every clearance here is in the API, with alerts when new ones post.