CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS— 510(k) K860293
Substantially EquivalentDifco Laboratories, Inc.
FDA 510(k) clearance K860293 for CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS, Substantially Equivalent on 1986-02-05. Applicant: Difco Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Difco Laboratories, Inc.
- Product code
- Code KIR
- Device class
- Class 1
- Regulation
- 21 CFR 864.2280
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
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