ALPHA-THAL SCREEN TM CONTROL
FDA 510(k) clearance K810976 · decided 1981-05-29
Clearance details
- K-number
- K810976
- Device name
- ALPHA-THAL SCREEN TM CONTROL
- Applicant
- Isolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-04-10
- Decision date
- 1981-05-29
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LGL
- Device class
- 2
- Regulation number
- 864.7500
- 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 |
|---|---|---|
| ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT (K801771) | Isolab, Inc. | 1981-01-16 |
Recalls involving this device
No recalls on record reference this clearance.