K900107 is an FDA 510(k) clearance for the LD-1. This device is classified as a Lactic Dehydrogenase, Antigen, Antiserum, Control (Class I - General Controls, product code DET).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 18, 1990, 9 days after receiving the submission on January 9, 1990.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5560.
| 510(k) Number | K900107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1990 |
| Decision Date | January 18, 1990 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DET — Lactic Dehydrogenase, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5560 |