MYCOPLASMA IGM ELISA TEST SYSTEM— 510(k) K971503
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K971503 for MYCOPLASMA IGM ELISA TEST SYSTEM, Substantially Equivalent on 1997-08-20. Applicant: Zeus Scientific, Inc.. Device class: 1.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code LJZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3375
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.