ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)— 510(k) K970126
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K970126 for ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545), Substantially Equivalent on 1997-02-25. Applicant: Bio-Rad Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code CHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
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More clearances from Bio-Rad Laboratories, Inc.
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