K841800 is an FDA 510(k) clearance for the LYSING & HEMOGLOBIN REAGENT. This device is classified as a Products, Red-cell Lysing Products (Class I - General Controls, product code GGK).
Submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1984, 43 days after receiving the submission on April 18, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8540.
| 510(k) Number | K841800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 1984 |
| Decision Date | May 31, 1984 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GGK — Products, Red-cell Lysing Products |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8540 |