Clear-Rite 3
FDA 510(k) K832451 · Richard-Allan Medical Ind., Inc.
510(k) numberK832451
Submission
- Device name
- Clear-Rite 3
- Applicant
- Richard-Allan Medical Ind., Inc.
Mchenry, IL, US - Received
- July 25, 1983
- Decision date
- August 12, 1983
- 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 |
| K861490 | Permaclear Solution Cat. No. 4950KEM · Traditional | Helena Laboratories | 05/06/1986SE |
| 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 |
| K832011 | Ameri ClearKEM · Traditional | Stephens Scientific | 08/12/1983SE |
| K830627 | Clarifier-Richard-AllanKEM · Traditional | Richard-Allan Medical Ind., Inc. | 03/24/1983SE |
More from Richard-Allan Medical Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931879 | Reflex HTRGCJ · Traditional | 03/24/1994SE |
| K924200 | Reflex(R) EscKNF · Traditional | 02/22/1994SE |
| K926297 | Reflex EsiGEI · Traditional | 10/15/1993SE |
| K924761 | Sterile Endoscopic Dispos Trocars W/Safe ShieldGCJ · Traditional | 04/20/1993SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | 05/03/1990SE |
| K896262 | Titanium Ligating ClipsHBT · Traditional | 01/02/1990SE |
| K890314 | Protector (Surgical Instrument)MMK · Traditional | 02/27/1989SE |
| K873309 | Reflex(Tm) Ca-T Clip ApplierFZP · Traditional | 11/27/1987SE |
| K862404 | Reflex(Tm) Clip ApplierFZP · Traditional | 07/23/1986SE |
| K862223 | Micro Thin* ParaffinKEO · Traditional | 06/17/1986SE |
Questions and answers
When was Clear-Rite 3 cleared by the FDA?
Clear-Rite 3 (K832451) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 18 days after the submission was received.
What is the product code of K832451?
The FDA product code is KEM – Agent, Clearing, a Class I (low risk) device regulated under 21 CFR 864.4010.