Medical Device Manufacturer · US , Parsippany , NJ

American Bioproducts Co. - FDA 510(k) Cleared Devices

79 submissions · 75 cleared · Since 1985
79
Total
75
Cleared
0
Denied
79 devices
26-50 of 79
Cleared Mar 01, 1994
STAGO FACTOR II-DEFICIENT PLASMA
K934606 · GJT
Hematology · 155d
Cleared Nov 15, 1993
STAGO FACTOR IX-DEFICIENT PLASMA
K933432 · GJT
Hematology · 124d
Cleared Nov 05, 1993
NEW STACHROM PROTEIN C TEST KIT
K931906 · GGP
Hematology · 206d
Cleared Oct 27, 1993
STAGO FACTOR XII-DEFICIENT PLASMA
K933438 · GJT
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR VII-DEFICIENT PLASMA
K933440 · GJT
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR X-DEFICIENT PLASMA
K933441 · GJT
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR XI-DEFICIENT PLASMA
K933444 · GJT
Hematology · 105d
Cleared Aug 09, 1993
STACLOT(R) PNP TEST KIT
K924370 · GGW
Hematology · 346d
Cleared May 20, 1993
FACTOR CONTROL [P]
K930959 · GGC
Hematology · 85d
Cleared Apr 27, 1993
COAG-CONTROL
K930923 · GGC
Hematology · 63d
Cleared Dec 23, 1992
STACLOT LA TEST KIT
K923731 · GFO
Hematology · 149d
Cleared Dec 07, 1992
NEOPLASTINE(R) CI KIT
K922565 · GJS
Hematology · 189d
Cleared Oct 26, 1992
COAG-CONTROL [N] KIT
K922174 · GGN
Hematology · 171d
Cleared Sep 23, 1992
NEW STACHROM ANTIPLASMIN
K921449 · GGP
Hematology · 181d
Cleared Jul 13, 1992
FDP PLASMA TEST KIT
K920943 · DAP
Hematology · 137d
Cleared Jun 23, 1992
NEOPLASTINE CI PLUS
K922040 · GJS
Hematology · 53d
Cleared Jun 09, 1992
THROMBO-CALIBRATOR KIT
K921344 · GGN
Hematology · 82d
Cleared Jun 09, 1992
AVK CONTROL I & II
K921665 · GGC
Hematology · 63d
Cleared Jun 09, 1992
PTT-LA TEST KIT
K921684 · GGW
Hematology · 62d
Cleared Jun 09, 1992
UNICALIBRATOR KIT
K922021 · GIZ
Hematology · 40d
Cleared Oct 08, 1991
STACLOT(R) PROTEIN S TEST KIT
K913424 · GGP
Hematology · 68d
Cleared Oct 02, 1991
LIATEST PROTEIN S KIT
K912468 · GGP
Hematology · 120d
Cleared Jan 24, 1991
LIATEST(R) AT III TEST KIT
K905110 · JBQ
Hematology · 72d
Cleared Nov 13, 1990
ST-4 COAGULATION INSTRUMENT
K904297 · GKP
Hematology · 55d
Cleared Jun 23, 1989
THE STAGO VIII DEFICIENT PLASMA KIT
K892859 · GGP
Hematology · 66d

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