Dropper, Cepti-Seal Koh Solution
FDA 510(k) K781869 · Marion Laboratories, Inc.
510(k) numberK781869
Submission
- Device name
- Dropper, Cepti-Seal Koh Solution
- Applicant
- Marion Laboratories, Inc.
Mchenry, IL, US - Received
- November 3, 1978
- Decision date
- November 22, 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 |
| K781868 | Dropper, Cepti-Seal LavtophenolKEQ · Traditional | Marion Laboratories, Inc. | 11/22/1978SE |
| K781388 | F.A. Mounting MediumKEQ · Traditional | Flow Laboratories, Inc. | 08/21/1978SE |
More from Flow Laboratories, Inc.
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| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K874553 | Envisan PasteKOZ · Traditional | 12/18/1987SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
Questions and answers
When was Dropper, Cepti-Seal Koh Solution cleared by the FDA?
Dropper, Cepti-Seal Koh Solution (K781869) received a 510(k) decision of Substantially Equivalent on November 22, 1978, 19 days after the submission was received.
What is the product code of K781869?
The FDA product code is KEQ – Media, Mounting, Water Soluble, a Class I (low risk) device regulated under 21 CFR 864.4010.