PR-3 ELISA TEST SYSTEM
FDA 510(k) clearance K961764 · decided 1996-08-19
Clearance details
- K-number
- K961764
- Device name
- PR-3 ELISA TEST SYSTEM
- Applicant
- Immunoprobe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-07
- Decision date
- 1996-08-19
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- MOB
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Frederick, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.