Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

79 results for "American Bioproducts Co."
1–24 of 79
Search insights Median review: 97d Cleared: 100% Top manufacturer: American Bioproducts Co. Lead specialty: Hematology
Cleared Nov 12, 1998
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · JPA
American Bioproducts Co.
Hematology · 43d
Cleared Aug 19, 1997
ASSERACHROM TPA TEST KIT
K971519 · GGP
American Bioproducts Co.
Hematology · 116d
Cleared Jun 26, 1997
STA-LIATEST D-DI TEST KIT
K964728 · DAP
American Bioproducts Co.
Hematology · 213d
Cleared Jun 26, 1997
STA LIATEST CONTROL [N]+[P] KIT
K964716 · GGN
American Bioproducts Co.
Hematology · 213d
Cleared May 23, 1997
STA D-DI CALIBRATOR KIT
K964718 · DAP
American Bioproducts Co.
Hematology · 179d
Cleared Oct 25, 1996
STA - LIATEST VWF TEST KIT
K962675 · GJT
American Bioproducts Co.
Hematology · 108d
Cleared Sep 13, 1996
STA-VWF CALIBRATOR KIT
K962671 · GJT
American Bioproducts Co.
Hematology · 66d
Cleared Jul 23, 1996
STA - VWF CONTROL [N]+[P] KIT
K962674 · GGN
American Bioproducts Co.
Hematology · 14d
Cleared Jul 10, 1996
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · GKP
American Bioproducts Co.
Hematology · 77d
Cleared Jan 31, 1996
AT-III CONTROL PLASMA KIT
K955040 · GGC
American Bioproducts Co.
Hematology · 89d
Cleared Nov 13, 1995
ASSERACHROM TOTAL PROTEIN S KIT
K954040 · GGP
American Bioproducts Co.
Hematology · 77d
Cleared Nov 13, 1995
ASSERACHROM FREE PROTEIN S KIT
K954017 · GGP
American Bioproducts Co.
Hematology · 80d
Cleared Sep 26, 1995
HEPARIN CONTROL KIT
K943520 · KFF
American Bioproducts Co.
Hematology · 432d
Cleared Sep 26, 1995
HBPM/LMWH CONTROL KIT
K943519 · KFF
American Bioproducts Co.
Hematology · 432d
Cleared Sep 26, 1995
THE HEPANORM HBPM/LMWH KIT
K943514 · KFF
American Bioproducts Co.
Hematology · 432d
Cleared Sep 21, 1995
STA-COAG CONTROL [P] PLUS KIT
K952338 · GGC
American Bioproducts Co.
Hematology · 125d
Cleared Aug 31, 1995
ROTACHROM HBPM/LMWH TEST KIT
K943516 · KFF
American Bioproducts Co.
Hematology · 406d
Cleared Aug 31, 1995
ROTACHROM HEPARIN TEST KIT
K943515 · KFF
American Bioproducts Co.
Hematology · 406d
Cleared May 23, 1995
THE STACHROM HEPARIN ASSAY KIT
K925433 · KFF
American Bioproducts Co.
Hematology · 937d
Cleared May 11, 1995
STACLOT HEPARIN TEST KIT
K943517 · KFF
American Bioproducts Co.
Hematology · 294d
Cleared Apr 07, 1995
AT-III CALIBRATOR
K944279 · JBQ
American Bioproducts Co.
Hematology · 220d
Cleared Mar 21, 1995
STA SYSTEM CONTROL [N] + [P] KIT
K943518 · GGN
American Bioproducts Co.
Hematology · 243d
Cleared Mar 21, 1995
PTT-LT TEST KIT
K941210 · GGW
American Bioproducts Co.
Hematology · 372d
Cleared Feb 01, 1995
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · GKP
American Bioproducts Co.
Hematology · 274d