510(k) K955638
- Device
- SYNTHAFAX APTT REAGENT
- Applicant
- ORTHO DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K955638
- Product code
- GFO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-23
- Date received
- 1995-12-11
- Regulation
- 864.7925
- Classification name
- Activated 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
- BLANCHE CHIEN
- Address
- 1001 U.S. Hwy. 202 P.O Box 350 Raritan NJ US 08869 08869
FDA Registration Numbers#
- 3002721930
- 3013660430
- 9710666
- 1217183
- 1832216
- 3003691680
- 2431530
- 8043599
- 1181121
- 3037000637
- 9610806
- 1618982
- 2245451
- 3008386529
Source Documents#
Other 510(k) Records For Product Code GFO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | 2026-01-09 |
| K193556 | Cryocheck Hex LA | Precision Biologic | 2020-10-23 |
| K160445 | HemosIL Silica Clotting Time | Instrumentation Laboratory CO | 2016-03-16 |
| K053111 | STA-CEPHASCREEN KIT | Diagnostica Stago, Inc. | 2006-05-04 |
| K060688 | HEMOSIL SYNTHASIL | Instrumentation Laboratory CO | 2006-04-13 |
| K050221 | HEMOSIL SILICA CLOTTING TIME | Instrumentation Laboratory CO | 2005-03-30 |
| K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | Vital Scientific N.V. | 2002-11-01 |
| K014028 | CARESIDE APTT | Careside Hemotology, Inc. | 2002-02-08 |
| K014008 | HEMOCHRON JR. CITRATE APTT CUVETTE | Itc, Inc. | 2002-01-24 |
| K992712 | SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 | Sigma Diagnostics, Inc. | 1999-12-06 |
| K992711 | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 | Sigma Diagnostics, Inc. | 1999-12-06 |
| K972831 | HEMOCHRON CITRATE APTT | International Technidyne Corp. | 1997-11-20 |
| K973306 | IL TEST APTT-SP | Instrumentation Laboratory CO | 1997-11-04 |
| K961892 | SPECKTIN-LA TEST SET | Analytical Control Systems, Inc. | 1997-03-07 |
| K955450 | PATHROMTIN SL | Behring Diagnostics, Inc. | 1996-04-19 |
Legacy Summary#
summary
FDA Review#
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