Panels › Hematology › Product code GGN · Class 2
Plasma, Coagulation Control
Regulation 864.5425
0510(k)s in 12 months (99 all time)
2recalls in 12 months (16 all time)
15recalls that name a 510(k)
Top companies in GGN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 1999 | K992278 | HEPARIN CONTROL PLASMA LEVEL 1 Pacific Hemostasis | GGN |
| Apr 21, 1999 | K990858 | LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 Bio-Rad | GGN |
| Jun 15, 1998 | K981752 | I-STAT COAGULATION CONTROL SET Biopool Intl., Inc. | GGN |
| Apr 29, 1998 | K981255 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL III Sigma Diagnostics, Inc. | GGN |
| Apr 29, 1998 | K981254 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL II Sigma Diagnostics, Inc. | GGN |
| Apr 29, 1998 | K981248 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL I Sigma Diagnostics, Inc. | GGN |
| Apr 27, 1998 | K981178 | THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS Cardiovascular Diagnostics, Inc. | GGN |
| Apr 16, 1998 | K980982 | AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 Avocet Medical, Inc. | GGN |
| Aug 29, 1997 | K971219 | CRYO CHECK INR VALIDATION SET Precision Biologicals, Inc., CA | GGN |
| Aug 19, 1997 | K971222 | CRYO CHECK APC RESISTANT PLASMA Precision Biologicals, Inc., CA | GGN |
| Jun 26, 1997 | K964716 | STA LIATEST CONTROL [N]+[P] KIT American Bioproducts Co. | GGN |
| Jun 17, 1997 | K971428 | COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 Pacific Hemostasis | GGN |
| May 29, 1997 | K971748 | TAS PT-NCTEST CONTROLS Cardiovascular Diagnostics, Inc. | GGN |
| Feb 20, 1997 | K964963 | LYPHOCHEK COAGULATION CONTROL Bio-Rad | GGN |
| Jul 23, 1996 | K962674 | STA - VWF CONTROL [N]+[P] KIT American Bioproducts Co. | GGN |
| Jun 5, 1996 | K961189 | TAS A PTT TEST CONTROLS Cardiovascular Diagnostics, Inc. | GGN |
| May 30, 1996 | K960234 | TAS HMT CONTROLS Cardiovascular Diagnostics, Inc. | GGN |
| May 30, 1996 | K955278 | BEHRING COAGULATION TIMER Behring Diagnostics, Inc. | GGN |
| Mar 11, 1996 | K952321 | PORCINE FACTOR VIII;C REAGENT Helena Laboratories | GGN |
| Jan 3, 1996 | K951823 | CRYO CHECK LOW FIBRINOGEN CONTROL Precision Biologicals, Inc., CA | GGN |
| Oct 30, 1995 | K952622 | CRYO CHECK NORMAL HUMAN REFERENCE PLASMA Precision Biologicals, Inc., CA | GGN |
| Oct 24, 1995 | K945855 | A-FACT, ABNORMAL FACTOR ASSAY CONTROL George King Bio-Medical, Inc. | GGN |
| Oct 24, 1995 | K945854 | B-FACT, BORDERLINE FACTOR ASSAY CONTROL George King Bio-Medical, Inc. | GGN |
| May 11, 1995 | K940209 | ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL Ortho Diagnostic Systems, Inc. | GGN |
| Mar 21, 1995 | K943518 | STA SYSTEM CONTROL [N] + [P] KIT American Bioproducts Co. | GGN |
| Mar 15, 1995 | K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II International Technidyne Corp. | GGN |
| Sep 14, 1994 | K941860 | SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) Helena Laboratories | GGN |
| Mar 22, 1994 | K933277 | COAGULATION A.R.P. Helena Laboratories | GGN |
| Feb 25, 1993 | K922887 | CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM Precision Biologicals, Inc., CA | GGN |
| Dec 1, 1992 | K924404 | CLIBRATION PLASMAS Behring Diagnostics, Inc. | GGN |
| Oct 26, 1992 | K922174 | COAG-CONTROL [N] KIT American Bioproducts Co. | GGN |
| Jun 9, 1992 | K921344 | THROMBO-CALIBRATOR KIT American Bioproducts Co. | GGN |
| Mar 4, 1992 | K914949 | COAGULATION ARPR,CAT.NO.5185 Helena Laboratories | GGN |
| Aug 22, 1991 | K911777 | ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED Helena Laboratories | GGN |
| Feb 11, 1991 | K905673 | AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 Helena Laboratories | GGN |
| Jul 26, 1990 | K902363 | COAGULATION CONTROL, LEVEL III Sigma Chemical Co. | GGN |
| Jul 26, 1990 | K902362 | COAGULATION CONTROL, LEVEL II Sigma Chemical Co. | GGN |
| Jul 26, 1990 | K902361 | COAGULATION CONTROL, LEVEL I Sigma Chemical Co. | GGN |
| Jul 3, 1990 | K902210 | ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA Ortho Diagnostic Systems, Inc. | GGN |
| Jan 25, 1990 | K900019 | ROCKET REFERENCE PLASMA, CAT NO. 5188 Helena Laboratories | GGN |
| Feb 2, 1989 | K884901 | DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO Baxter Healthcare Corp | GGN |
| Jan 30, 1989 | K884854 | COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) Precision Biologicals, Inc., CA | GGN |
| Aug 30, 1988 | K882481 | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II International Technidyne Corp. | GGN |
| Aug 30, 1988 | K882480 | HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II International Technidyne Corp. | GGN |
| May 2, 1988 | K881348 | VERIFY(R) REFERENCE PLASMA Organon Teknika Corp. | GGN |
| Feb 19, 1988 | K880302 | CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER Hemotec, Inc. | GGN |
| Apr 23, 1984 | K840288 | DIACELIN Diatech, Inc. | GGN |
| Feb 3, 1984 | K834086 | CONTACT-K APTT REAGENT Pacific Hemostasis | GGN |
| Aug 22, 1977 | K771346 | CI-TROL COAGULATION CONTROLS II & III Dade, Baxter Travenol Diagnostics, Inc. | GGN |
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