Submission Details
| 510(k) Number | K973517 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 17, 1997 |
| Decision Date | September 25, 1997 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
Sep 1997
Decision
8d
Days
Class 1
Risk
About This 510(k) Submission
K973517 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on September 25, 1997, 8 days after receiving the submission on September 17, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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