K883208 is an FDA 510(k) clearance for the HISTO-CHECK SLIDES. This device is classified as a Quality Control Slides (Class I - General Controls, product code LJG).
Submitted by Val Tech Diagnostics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 25, 1988, 27 days after receiving the submission on July 29, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K883208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1988 |
| Decision Date | August 25, 1988 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LJG — Quality Control Slides |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |