Rim E.Coli 0157:H7 Latex Test
FDA 510(k) K933457 · Remel Co.
510(k) numberK933457
Submission
- Device name
- Rim E.Coli 0157:H7 Latex Test
- Applicant
- Remel Co.
Lenexa, KS, US - Received
- July 14, 1993
- Decision date
- April 20, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GNA – Antisera, All Types, Escherichia Coli
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3255
- Specialty
- Microbiology
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| K953362 | Premier EhecGNA · Traditional | Meridian Diagnostics, Inc. | 11/14/1995SE |
| K950167 | Premier EhecGNA · Traditional | Meridian Diagnostics, Inc. | 04/14/1995SE |
| K903714 | E. Coli 0157 Latex TestGNA · Traditional | Pro-Lab, Inc. | 01/24/1991SE |
| K884026 | Escherichia Coli 0157 Latex Agglutination Test KitGNA · Traditional | Oxoid U.S.A., Inc. | 02/03/1989SE |
| K874288 | Phadebact Etec-Lt TestGNA · Traditional | Pharmacia, Inc. | 09/02/1988SE |
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Questions and answers
When was Rim E.Coli 0157:H7 Latex Test cleared by the FDA?
Rim E.Coli 0157:H7 Latex Test (K933457) received a 510(k) decision of Substantially Equivalent on April 20, 1994, 280 days after the submission was received.
What is the product code of K933457?
The FDA product code is GNA – Antisera, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.