SCOTTS TAP WATER SUBSTITUTE CONCENTRATE
FDA 510(k) clearance K830515 · decided 1983-03-31
Clearance details
- K-number
- K830515
- Device name
- SCOTTS TAP WATER SUBSTITUTE CONCENTRATE
- Applicant
- Surgipath Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-17
- Decision date
- 1983-03-31
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- KEQ
- 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 |
|---|---|---|
| VASPAR SEALANT (K792702) | Meridian Diagnostics, Inc. | 1980-01-24 |
| KOH MOUNTING FLUID W/GLYCEROL (K792709) | Meridian Diagnostics, Inc. | 1980-01-24 |
| LACTO-PHENOL ANALINE BLUE FLUID (K792703) | Meridian Diagnostics, Inc. | 1980-01-24 |
| DROPPER, CEPTI-SEAL LAVTOPHENOL (K781868) | Marion Laboratories, Inc. | 1978-11-22 |
| DROPPER, CEPTI-SEAL KOH SOLUTION (K781869) | Marion Laboratories, Inc. | 1978-11-22 |
| F.A. MOUNTING MEDIUM (K781388) | Flow Laboratories, Inc. | 1978-08-21 |
Recalls involving this device
No recalls on record reference this clearance.