QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL
FDA 510(k) clearance K820630 · decided 1982-06-25
Clearance details
- K-number
- K820630
- Device name
- QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL
- Applicant
- Isolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-08
- Decision date
- 1982-06-25
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- JPC
- Device class
- 2
- Regulation number
- 864.7455
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Isolab
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.