K781516 is an FDA 510(k) clearance for the TEST SYSTEM TISSUE CELL CULTURE SLIDE. This device is classified as a Chamber, Slide Culture (Class I - General Controls, product code KIY).
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978, 27 days after receiving the submission on August 31, 1978.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2240.
| 510(k) Number | K781516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 1978 |
| Decision Date | September 27, 1978 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KIY — Chamber, Slide Culture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2240 |