QUANTI. COLORI. DET. OF SERUM IRON
FDA 510(k) clearance K770495 · decided 1977-06-08
Clearance details
- K-number
- K770495
- Device name
- QUANTI. COLORI. DET. OF SERUM IRON
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-14
- Decision date
- 1977-06-08
- Days to decision
- 86 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sigma Chemical Co.
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.