DETER. OF PHOSPHOHEXOSE ISOMERASE
FDA 510(k) clearance K770577 · decided 1977-06-17
Clearance details
- K-number
- K770577
- Device name
- DETER. OF PHOSPHOHEXOSE ISOMERASE
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-28
- Decision date
- 1977-06-17
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- KLJ
- Device class
- 1
- Regulation number
- 862.1570
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.