MODIFICATION OF ABL MIC-10 PRECEPT SYS
FDA 510(k) clearance K843612 · decided 1985-02-19
Clearance details
- K-number
- K843612
- Device name
- MODIFICATION OF ABL MIC-10 PRECEPT SYS
- Applicant
- Austin Biological Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1984-09-13
- Decision date
- 1985-02-19
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- LTD
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Austin, TX, 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 |
|---|---|---|
| API UNISCEPT MIC (K843732) | Analytical Products, Inc. | 1984-10-24 |
Recalls involving this device
No recalls on record reference this clearance.