HEMOGLOBIN SCREENING DEVICE
FDA 510(k) clearance K882101 · decided 1988-07-01
Clearance details
- K-number
- K882101
- Device name
- HEMOGLOBIN SCREENING DEVICE
- Applicant
- Portable Medical Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-11
- Decision date
- 1988-07-01
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- KSL
- Device class
- 1
- Regulation number
- 864.9320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Solana Beach, CA, 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 |
|---|---|---|
| COPPER SULFATE SOLUTION SP. GR.1.055 (K803095) | Accra Laboratories, Inc. | 1981-03-06 |
Recalls involving this device
No recalls on record reference this clearance.