HEMATOLOGY DATA MANAGEMENT SYS
FDA 510(k) clearance K821534 · decided 1982-06-10
Clearance details
- K-number
- K821534
- Device name
- HEMATOLOGY DATA MANAGEMENT SYS
- Applicant
- Biovation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-24
- Decision date
- 1982-06-10
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- JGP
- Device class
- 2
- Regulation number
- 862.1635
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, 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 |
|---|---|---|
| MICROPROTEIN REAGENT SET (K070757) | Pointe Scientific, Inc., | 2007-12-04 |
| VITROS CHEMISTRY PRODUCTS UPRO SLIDES (K964960) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-18 |
| PROTEINMETER (K863112) | J. D. Assoc. | 1986-12-10 |
| MICRO LOWRY PROTEINTEST (K792347) | Panmed, Inc. | 1979-12-06 |
Recalls involving this device
No recalls on record reference this clearance.