PG-NUMERIC(TM)
FDA 510(k) clearance K883411 · decided 1989-03-15
Clearance details
- K-number
- K883411
- Device name
- PG-NUMERIC(TM)
- Applicant
- Isolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-15
- Decision date
- 1989-03-15
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- JHF
- Device class
- 2
- Regulation number
- 862.1455
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Akron, OH, 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 |
|---|---|---|
| TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II (K940817) | Abbott Laboratories | 1995-02-08 |
Recalls involving this device
No recalls on record reference this clearance.