510(k) K781388
- Device
- F.A. MOUNTING MEDIUM
- Applicant
- FLOW LABORATORIES, INC.
- 510(k) number
- K781388
- Product code
- KEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-21
- Date received
- 1978-08-10
- Regulation
- 864.4010
- Classification name
- Media, Mounting, Water Soluble
- Medical specialty
- Pathology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2083544
- 3019387954
- 1831638
- 3004074729
- 1419341
- 1000391282
- 9610140
- 1640981
- 3015376545
- 3009963993
- 3007496191
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KEQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K830515 | SCOTTS TAP WATER SUBSTITUTE CONCENTRATE | Surgipath Medical Industries, Inc. | 1983-03-31 |
| K792702 | VASPAR SEALANT | Meridian Diagnostics, Inc. | 1980-01-24 |
| K792703 | LACTO-PHENOL ANALINE BLUE FLUID | Meridian Diagnostics, Inc. | 1980-01-24 |
| K792709 | KOH MOUNTING FLUID W/GLYCEROL | Meridian Diagnostics, Inc. | 1980-01-24 |
| K781868 | DROPPER, CEPTI-SEAL LAVTOPHENOL | Marion Laboratories, Inc. | 1978-11-22 |
| K781869 | DROPPER, CEPTI-SEAL KOH SOLUTION | Marion Laboratories, Inc. | 1978-11-22 |
Legacy Summary#
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FDA Review#
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