KOH MOUNTING FLUID
FDA 510(k) clearance K812193 · decided 1981-08-31
Clearance details
- K-number
- K812193
- Device name
- KOH MOUNTING FLUID
- Applicant
- American Scientific Products
- Decision
- Substantially Equivalent
- Date received
- 1981-08-03
- Decision date
- 1981-08-31
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- LEB
- 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 |
|---|---|---|
| REFRAX MOUNTING MEDIUM (K842986) | Anatech, Ltd. | 1984-08-21 |
| PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU (K821019) | Microbiological Research Corp. | 1982-04-26 |
| CLEAR-MOUNT (K811799) | Richard-Allan Medical Ind., Inc. | 1981-07-31 |
| LACTO-PHENOL COTTON BLUE MOUNTING FL. (K760838) | I M, Inc. | 1976-11-16 |
Recalls involving this device
No recalls on record reference this clearance.