DETECTACULT— 510(k) K854619
Substantially EquivalentImmunostics Co., Inc.
FDA 510(k) clearance K854619 for DETECTACULT, Substantially Equivalent on 1986-03-03. Applicant: Immunostics Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Immunostics Co., Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Metuchen, NJ, US
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