GENERAL DIAGNOSTICS COAG-A-MATE XC
FDA 510(k) clearance K852843 · decided 1985-08-13
Clearance details
- K-number
- K852843
- Device name
- GENERAL DIAGNOSTICS COAG-A-MATE XC
- Applicant
- Warner-Lambert Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-05
- Decision date
- 1985-08-13
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- KQC
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Morris Plains, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FIELDTEX HEMATOXYLIN (K882873) | Anatech, Ltd. | 1988-07-28 |
| RETIC-SET (K843619) | R&D Systems, Inc. | 1984-10-30 |
| RETIC-SET (K841848) | R&D Systems, Inc. | 1984-05-31 |
| PONCEAU S STAIN SET (K792550) | Electrophoresis Corp. of America | 1980-01-16 |
| VOLU-SOL NMB RETICULOCYTE STAIN (K792496) | Volu Sol Medical Industries | 1979-12-31 |
| STAT DIFF STAIN (K791007) | Bioscientific | 1979-08-03 |
| HEMASTAIN FIXATIVE (K760485) | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
| HEMASTAIN PHOSPHATE BUFFER (K760487) | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S004) | Warner-Lambert Co. | 1988-04-12 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S003) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S002) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S001) | Warner-Lambert Co. | 1983-11-25 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024) | Warner-Lambert Co. | 1982-03-04 |