Submission Details
| 510(k) Number | K881932 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 10, 1988 |
| Decision Date | August 01, 1988 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
Cleared
Traditional
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
Aug 1988
Decision
83d
Days
Class 2
Risk
About This 510(k) Submission
K881932 is an FDA 510(k) clearance for the ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT, a Antigen, Cf (including Cf Control), Cytomegalovirus (Class II — Special Controls, product code GQH), submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on August 1, 1988, 83 days after receiving the submission on May 10, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.
Device Classification
| Product Code | GQH — Antigen, Cf (including Cf Control), Cytomegalovirus |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3175 |
Manufacturer
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