THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.— 510(k) K984153
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K984153 for THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM., Substantially Equivalent on 1999-01-11. 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
- Raritan, NJ, US
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