COUNTER CHECK, H001, H002, H003
FDA 510(k) clearance K790025 · decided 1979-01-17
Clearance details
- K-number
- K790025
- Device name
- COUNTER CHECK, H001, H002, H003
- Applicant
- Diagnostic Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-01-03
- Decision date
- 1979-01-17
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KSF
- Device class
- 2
- Regulation number
- 864.9650
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| AVI-D CONTROL (K811713) | Ortho Diagnostic Systems, Inc. | 1981-10-23 |
| DADE RH CONTROL REAGENT (K810599) | American Dade | 1981-03-31 |
| RH CONTROL (K801425) | North American Biologicals, Inc. | 1980-07-14 |
| RST-SERIES CONTROL (K800658) | Gamma Biologicals, Inc. | 1980-04-16 |
| ORTHO ANTISERA CONTROL (K800310) | Ortho Diagnostics, Inc. | 1980-03-05 |
| RH-HR NEGATIVE CONTROL REAGENT (K800239) | Gotham Biologics, Inc. | 1980-02-21 |
| TEST CELLS (K790249) | Hyland Therapeutic Div., Travenol Laboratories | 1979-05-16 |
| RECAP (K780665) | Bca Biological Corp. of America | 1978-06-06 |
| QUALITY CONTROL SYSTEM, SPECTRA (K780097) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 |
| REAGENT CONFIDENCE SERA (K771814) | Ortho Diagnostics, Inc. | 1977-11-07 |
| UNIVAL CONTROL CELLS (K761284) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-01-25 |
Recalls involving this device
No recalls on record reference this clearance.