K841026 is an FDA 510(k) clearance for the MANUAL BLOOD CELL COUNTING DEVICE. This device is classified as a Hand-tally, Differential (Class I - General Controls, product code GKM).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984, 23 days after receiving the submission on March 12, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6160.
| 510(k) Number | K841026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1984 |
| Decision Date | April 04, 1984 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKM — Hand-tally, Differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6160 |