ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV— 510(k) K990377
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K990377 for ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV, Substantially Equivalent on 1999-02-26. Applicant: Roche Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics Corp.
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