F.A. Mounting Medium
FDA 510(k) K781388 · Flow Laboratories, Inc.
510(k) numberK781388
Submission
- Device name
- F.A. Mounting Medium
- Applicant
- Flow Laboratories, Inc.
Mchenry, IL, US - Received
- August 10, 1978
- Decision date
- August 21, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KEQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K830515 | Scotts Tap Water Substitute ConcentrateKEQ · Traditional | Surgipath Medical Industries, Inc. | 03/31/1983SE |
| K792709 | Koh Mounting Fluid W/GlycerolKEQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K792703 | Lacto-Phenol Analine Blue FluidKEQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K792702 | Vaspar SealantKEQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K781869 | Dropper, Cepti-Seal Koh SolutionKEQ · Traditional | Marion Laboratories, Inc. | 11/22/1978SE |
| K781868 | Dropper, Cepti-Seal LavtophenolKEQ · Traditional | Marion Laboratories, Inc. | 11/22/1978SE |
More from Marion Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861897 | Uniskan IIJJQ · Traditional | 07/01/1986SE |
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| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | 05/20/1986SE |
| K860762 | Gamma-Free Horse SerumKIS · Traditional | 03/10/1986SE |
| K860752 | Goat Serum (29-391-54)KIS · Traditional | 03/10/1986SE |
| K850908 | Titertek Microittration Equip. Handiwash 110 12CHAJTC · Traditional | 03/25/1985SE |
| K844567 | Titertek Twinreader 78-630-00JJQ · Traditional | 03/21/1985SE |
| K844419 | Titertek Multiskan MSS/340JJQ · Traditional | 03/21/1985SE |
Questions and answers
When was F.A. Mounting Medium cleared by the FDA?
F.A. Mounting Medium (K781388) received a 510(k) decision of Substantially Equivalent on August 21, 1978, 11 days after the submission was received.
What is the product code of K781388?
The FDA product code is KEQ – Media, Mounting, Water Soluble, a Class I (low risk) device regulated under 21 CFR 864.4010.