TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2— 510(k) K950128
Substantially EquivalentEmd Chemicals, Inc.
FDA 510(k) clearance K950128 for TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2, Substantially Equivalent on 1995-05-15. Applicant: Emd Chemicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Emd Chemicals, Inc.
- Product code
- Code CEK
- Device class
- Class 2
- Regulation
- 21 CFR 862.1635
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
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