Submission Details
| 510(k) Number | K973030 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 14, 1997 |
| Decision Date | September 04, 1997 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
Sep 1997
Decision
21d
Days
Class 1
Risk
About This 510(k) Submission
K973030 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300), 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 4, 1997, 21 days after receiving the submission on August 14, 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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