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Panels › Hematology › Product code JPK · Class 2

Mixture, Hematology Quality Control

Regulation 864.8625

0510(k)s in 12 months (192 all time)
0recalls in 12 months (16 all time)
15recalls that name a 510(k)
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Top companies in JPK

Company510(k)sRecalls
R&D Systems, Inc.452
Streck Laboratories, Inc.230
Streck120
Beckman Coulter, Inc.100
Coulter Electronics, Inc.80
Bhp Diagnostix, Inc.70
Clinical Diagnostic Solutions, Inc.16
Hematronix, Inc.60
American Dade50
Coulter Corp.50
Decided510(k)Device and applicantCode
Oct 10, 1980K802141CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
American Dade
JPK
Jul 14, 1980K801267RED BLOOD CELL COUNT & HEMATOCRIT CNTL
Bioscientific
JPK
Jul 14, 1980K801265WHITE BLOOD CELL COUNT CONTROL LEVELS
Bioscientific
JPK
May 8, 1980K800938TRI-CHECK
Scientific Standards, Inc.
JPK
Apr 24, 1980K800780SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS
Sandare Chemical Co., Inc.
JPK
Apr 4, 1980K800361HEMATO-CHEX
Streck Laboratories, Inc.
JPK
Feb 13, 1980K792606WHOLE BLOOD PLATELET CONTROL NORMAL,
Dade, Baxter Travenol Diagnostics, Inc.
JPK
Dec 31, 1979K792467PLATELET-CHEX FOR BLOOD CENTERS
Streck Laboratories, Inc.
JPK
Dec 4, 1979K792209SANDARE HEMOGLOBIN CONTROLS
Sandare Chemical Co., Inc.
JPK
Nov 5, 1979K792055FISHER DIAGNOSTICS HEMATOLOGY CONTROLS
Fisher Scientific Co., LLC
JPK
Oct 11, 1979K791772COUNTER-CHECK PLUS NORMAL, HIGH ABN.
Diagnostic Technology, Inc.
JPK
Oct 11, 1979K791750COUNTER-CHECK PLUS
Diagnostic Technology, Inc.
JPK
Aug 3, 1979K791228PARA-8
Streck Laboratories, Inc.
JPK
Aug 3, 1979K791227PARA-7
Streck Laboratories, Inc.
JPK
Aug 3, 1979K791226PLATELET-CHEX PLUS
Streck Laboratories, Inc.
JPK
Jun 22, 1979K791030HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL
Beckman Instruments, Inc.
JPK
May 31, 1979K790826COAGULATION ARP
Helena Laboratories
JPK
Apr 4, 1979K790457HEMOGLOBIN CONTROLS
Data Medical Associates, Inc.
JPK
Apr 4, 1979K790415HCP-7
Bioscientific
JPK
Apr 3, 1979K790525HEMATROL S HEMATOLOGY CONTROLS
Fisher Scientific Co., LLC
JPK
Jan 3, 1979K781969BLOOD, HEMATOLOGY REFERENCE CONTROL
Coulter Electronics, Inc.
JPK
Nov 15, 1978K781786QUANTICEL HHR # L500 AND L501
Bhp Diagnostix, Inc.
JPK
Nov 15, 1978K781745QUANTICEL HHR, L531 AND L532
Bhp Diagnostix, Inc.
JPK
Oct 17, 1978K781573ABNORMAL HEMATOLOGY CONTROL UNASSAYED
Ortho Diagnostics, Inc.
JPK
Oct 17, 1978K781572NORMAL HEMATOLOGY CONTROL UNASSAYED
Ortho Diagnostics, Inc.
JPK
Sep 14, 1978K781247QUANTICEL-HRP
Bhp Diagnostix, Inc.
JPK
Jul 27, 1978K781077CONTROL, HEMATOLOGY, CH-60
Dade, Baxter Travenol Diagnostics, Inc.
JPK
Jul 27, 1978K780980PLATELET CONTROL
Bhp Diagnostix, Inc.
JPK
Jun 22, 1978K780835ARANTROL
Aranco Diagnostic Laboratories, Inc.
JPK
Jun 6, 1978K780714PLATELET CONTROL
Bhp Diagnostix, Inc.
JPK
Mar 27, 1978K780140CELL-CHEX
Streck Laboratories, Inc.
JPK
Feb 3, 1978K772195HEMATOLOGY REFERENCE CONTROLS
R&D Systems, Inc.
JPK
Nov 28, 1977K771753HEMATOLOGY REFERENCE CONTROL
Coulter Electronics, Inc.
JPK
Apr 8, 1977K770384MNITROL HEMOTOL. REF. AND CONTROL
Bd Becton Dickinson Vacutainer Systems Preanalytic
JPK
Mar 21, 1977K770386LATELET, CONTROL, NORMAL & ABNORMAL
Bd Becton Dickinson Vacutainer Systems Preanalytic
JPK
Feb 28, 1977K770095PLATELET CONTROL, NORMAL & ABNORMAL
Bd Becton Dickinson Vacutainer Systems Preanalytic
JPK
Feb 16, 1977K770020PLATELET-CHEX-HUMAN
Streck Laboratories, Inc.
JPK
Oct 8, 1976K7606824C ABNORMAL LOW-HIGH (8 X 6 M1)
Coulter Electronics, Inc.
JPK
Oct 8, 1976K760597BIOTROL-NORMAL
Boehringer Mannheim Corp.
JPK
Oct 8, 1976K760596BIOTROL-ABNORMAL
Boehringer Mannheim Corp.
JPK
Oct 8, 1976K760549PLATELET CONTROLS, NORMAL & ABNORMAL
Dade, Baxter Travenol Diagnostics, Inc.
JPK
Aug 4, 1976K760162HEMATOLOGY CONTROL
Biological Corp. of America
JPK

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