MINISTAT-S CHEMISTRY ANALYZER
FDA 510(k) clearance K771591 · decided 1977-09-20
Clearance details
- K-number
- K771591
- Device name
- MINISTAT-S CHEMISTRY ANALYZER
- Applicant
- Biokinetix Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-19
- Decision date
- 1977-09-20
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- JJI
- Device class
- 1
- Regulation number
- 862.2500
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| CODA AUTOMATED EIA ANALYZER (K972024) | Bio-Rad | 1997-07-30 |
| ABBOTT IMX 2 ANALYZER (K944731) | Abbott Laboratories | 1994-12-19 |
| ABBOTT IMX2 ANALYER (K931970) | Abbott Laboratories | 1993-06-16 |
| RADIAS AUTOMATED IMMUNOASSAY SYSTEM (K930898) | Bio-Rad | 1993-04-21 |
| ANALYZER, IMPACT 100 (K790073) | Gilford Instrument Laboratories, Inc. | 1979-02-22 |
| QUICKRATE REACTION RATE ANALYZER (K780972) | Olympus Corp. | 1978-08-14 |
| LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE (K770401) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 |
Recalls involving this device
No recalls on record reference this clearance.