REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
FDA 510(k) clearance K893224 · decided 1989-06-20
Clearance details
- K-number
- K893224
- Device name
- REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-04-27
- Decision date
- 1989-06-20
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.