(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE— 510(k) K894845
Substantially EquivalentMeridian Diagnostics, Inc.
FDA 510(k) clearance K894845 for (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE, Substantially Equivalent on 1989-09-08. Applicant: Meridian Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Meridian Diagnostics, Inc.
- Product code
- Code GMD
- Device class
- Class 2
- Regulation
- 21 CFR 866.3165
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code GMD
view allMore clearances from Meridian Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.