Escherichia Coli 0157 Latex Agglutination Test Kit
FDA 510(k) K884026 · Oxoid U.S.A., Inc.
510(k) numberK884026
Submission
- Device name
- Escherichia Coli 0157 Latex Agglutination Test Kit
- Applicant
- Oxoid U.S.A., Inc.
Columbia, MD, US - Received
- September 23, 1988
- Decision date
- February 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K031367 | Duopath Verotoxins Glisa TestGNA · Traditional | Emd Chemicals, Inc. | 01/23/2004SE |
| K993401 | Dryspot E.Coli 0157 KitGNA · Traditional | Oxoid , Ltd. | 02/28/2000SE |
| K981734 | Vtec-Rpla SeikenGNA · Traditional | Denka Seiken'S | 09/22/1998SE |
| K962028 | Wellcolex E-Coli OI57 ZC60GNA · Traditional | Murex Diagnostics, Inc. | 11/01/1996SE |
| K953362 | Premier EhecGNA · Traditional | Meridian Diagnostics, Inc. | 11/14/1995SE |
| K950167 | Premier EhecGNA · Traditional | Meridian Diagnostics, Inc. | 04/14/1995SE |
| K933457 | Rim E.Coli 0157:H7 Latex TestGNA · Traditional | Remel Co. | 04/20/1994SE |
| K903714 | E. Coli 0157 Latex TestGNA · Traditional | Pro-Lab, Inc. | 01/24/1991SE |
| K874288 | Phadebact Etec-Lt TestGNA · Traditional | Pharmacia, Inc. | 09/02/1988SE |
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|---|---|---|
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | 06/09/1989SE |
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| K874303 | Staphylase TestLHT · Traditional | 11/06/1987SE |
| K872956 | Sorbitol Macconkey Agar No. 3 CM 813JSI · Traditional | 08/10/1987SE |
| K872135 | Mcbride Medium CM 819JSJ · Traditional | 06/15/1987SE |
| K870945 | Rabbit Plasma Fibrinogen Supplement SR 122JTL · Traditional | 06/10/1987SE |
| K862946 | Oxoid Signal Blood Culture SystemJSG · Traditional | 11/05/1986SE |
| K855236 | Diagnostic Reagent Tst-RplaGTN · Traditional | 11/04/1986SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | 11/04/1986SE |
| K855234 | Diagnostic Reagent Vet-RplaGNA · Traditional | 11/04/1986SE |
Questions and answers
When was Escherichia Coli 0157 Latex Agglutination Test Kit cleared by the FDA?
Escherichia Coli 0157 Latex Agglutination Test Kit (K884026) received a 510(k) decision of Substantially Equivalent on February 3, 1989, 133 days after the submission was received.
What is the product code of K884026?
The FDA product code is GNA – Antisera, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.