510(k) K941210
- Device
- PTT-LT TEST KIT
- Applicant
- AMERICAN BIOPRODUCTS CO.
- 510(k) number
- K941210
- Product code
- GGW
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 1995-03-21
- Date received
- 1994-03-14
- Regulation
- 864.7925
- Classification name
- Test, Time, Partial Thromboplastin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREW LOC B LE, PH.D
- Address
- 5 Century Dr. Parisppany NJ US 07054 07054
FDA Registration Numbers#
- 8043599
- 3004434070
- 3037000637
- 1000340866
- 1835316
- 2431530
- 1618982
- 3003691680
- 9710666
- 3013660430
- 1181055
- 9610806
- 2245451
Source Documents#
Other 510(k) Records For Product Code GGW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | 2026-03-20 |
| K090105 | LUPOTEK KCT | R2 Diagnostics, Inc. | 2010-12-30 |
| K083729 | HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN | Aniara Diagnostica, LLC | 2009-05-08 |
| K060284 | CRYOCHECK CLOT APCR | Precision Biologic, Inc. | 2006-05-10 |
| K042762 | PEFAKIT APC-R FACTOR V LEIDEN | Pentapharm , Ltd. | 2004-12-22 |
| K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE | R2 Diagnostics, Inc. | 2004-02-04 |
| K992456 | GRADILEIDEN V TEST | Gradipore , Ltd. | 1999-12-21 |
| K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | Precision Biologicals, Inc. | 1999-01-13 |
| K963111 | COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S | Chromogenix AB | 1996-12-23 |
| K945940 | COATEST(R) APC(TM) RESISTANCE | Axis-Shield Doc AS | 1995-08-07 |
| K924370 | STACLOT(R) PNP TEST KIT | American Bioproducts Co. | 1993-08-09 |
| K921684 | PTT-LA TEST KIT | American Bioproducts Co. | 1992-06-09 |
| K915463 | ACTIVATED PARTIAL THROMBOPLASTIN TIME | Sigma Diagnostics, Inc. | 1992-01-23 |
| K902236 | READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT | Biosearch Medical Products, Inc. | 1990-08-14 |
| K873382 | PLATELET EXTRACT REAGENT | Bio/Data Corp. | 1987-11-20 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases