K882101 is an FDA 510(k) clearance for the HEMOGLOBIN SCREENING DEVICE. This device is classified as a Solution, Copper Sulfate For Specific Gravity Determinations (Class I - General Controls, product code KSL).
Submitted by Portable Medical Laboratories, Inc. (Solana Beach, US). The FDA issued a Cleared decision on July 1, 1988, 51 days after receiving the submission on May 11, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9320.
| 510(k) Number | K882101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1988 |
| Decision Date | July 01, 1988 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSL — Solution, Copper Sulfate For Specific Gravity Determinations |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.9320 |