Permaclear Solution Cat. No. 4950
FDA 510(k) K861490 · Helena Laboratories
510(k) numberK861490
Submission
- Device name
- Permaclear Solution Cat. No. 4950
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- April 22, 1986
- Decision date
- May 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881282 | XyleneKEM · Traditional | Anatech, Ltd. | 04/05/1988SE |
| K874461 | Hemo-SolKEM · Traditional | Chem Pharm, Inc. | 12/04/1987SE |
| K855109 | Clearene, Clearing AgentKEM · Traditional | Surgipath Medical Industries, Inc. | 01/07/1986SE |
| K854083 | Xylene Substitute MontantKEM · Traditional | Lerner Laboratories, Inc. | 10/22/1985SE |
| K853694 | Xylene SubstituteKEM · Traditional | Lerner Laboratories, Inc. | 10/22/1985SE |
| K842861 | Pro-Par ClearantKEM · Traditional | Anatech, Ltd. | 08/21/1984SE |
| K842721 | LimoneneKEM · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K832451 | Clear-Rite 3KEM · Traditional | Richard-Allan Medical Ind., Inc. | 08/12/1983SE |
| K832011 | Ameri ClearKEM · Traditional | Stephens Scientific | 08/12/1983SE |
| K830627 | Clarifier-Richard-AllanKEM · Traditional | Richard-Allan Medical Ind., Inc. | 03/24/1983SE |
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Questions and answers
When was Permaclear Solution Cat. No. 4950 cleared by the FDA?
Permaclear Solution Cat. No. 4950 (K861490) received a 510(k) decision of Substantially Equivalent on May 6, 1986, 14 days after the submission was received.
What is the product code of K861490?
The FDA product code is KEM – Agent, Clearing, a Class I (low risk) device regulated under 21 CFR 864.4010.