CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
FDA 510(k) clearance K894389 · decided 1989-10-12
Clearance details
- K-number
- K894389
- Device name
- CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
- Applicant
- Catachem, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-17
- Decision date
- 1989-10-12
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GGX
- Device class
- 1
- Regulation number
- 864.6160
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Port Chester, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION (K902263) | Trimedyne, Inc. | 1990-07-23 |
Recalls involving this device
No recalls on record reference this clearance.