CARNOY'S SOLUTION
FDA 510(k) clearance K842737 · decided 1984-09-07
Clearance details
- K-number
- K842737
- Device name
- CARNOY'S SOLUTION
- Applicant
- E K Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-13
- Decision date
- 1984-09-07
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- IGM
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| VOLU-SOL CARNOY FLUID (K822126) | Volu Sol Medical Industries | 1982-08-05 |
| CULTURETTE BRAND PVA (K790815) | Marion Laboratories, Inc. | 1979-05-15 |
Recalls involving this device
No recalls on record reference this clearance.