Submission Details
| 510(k) Number | K905504 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 1990 |
| Decision Date | June 28, 1991 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
Cleared
Traditional
STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
Jun 1991
Decision
203d
Days
Class 2
Risk
About This 510(k) Submission
K905504 is an FDA 510(k) clearance for the STAINING SYSTEM FOR PNEUMOCYSTIS CARINII, a Pneumocystis Carinii (Class II — Special Controls, product code LYF), submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on June 28, 1991, 203 days after receiving the submission on December 7, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.
Device Classification
| Product Code | LYF — Pneumocystis Carinii |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3780 |
Manufacturer
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