Submission Details
| 510(k) Number | K914188 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 18, 1991 |
| Decision Date | August 26, 1992 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
Aug 1992
Decision
343d
Days
Class 2
Risk
About This 510(k) Submission
K914188 is an FDA 510(k) clearance for the KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on August 26, 1992, 343 days after receiving the submission on September 18, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.
Device Classification
| Product Code | JPA — System, Multipurpose For In Vitro Coagulation Studies |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5425 |
Manufacturer
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