Diagnostic Reagent Tst-Rpla
FDA 510(k) K855236 · Oxoid U.S.A., Inc.
510(k) numberK855236
Submission
- Device name
- Diagnostic Reagent Tst-Rpla
- Applicant
- Oxoid U.S.A., Inc.
Columbia, MD, US - Received
- December 31, 1985
- Decision date
- November 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTN – Antisera, Fluorescent, All Types, Staphylococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3700
- Specialty
- Microbiology
Other 510(k)s with product code GTN
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| K862946 | Oxoid Signal Blood Culture SystemJSG · Traditional | 11/05/1986SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | 11/04/1986SE |
| K855234 | Diagnostic Reagent Vet-RplaGNA · Traditional | 11/04/1986SE |
Questions and answers
When was Diagnostic Reagent Tst-Rpla cleared by the FDA?
Diagnostic Reagent Tst-Rpla (K855236) received a 510(k) decision of Substantially Equivalent on November 4, 1986, 308 days after the submission was received.
What is the product code of K855236?
The FDA product code is GTN – Antisera, Fluorescent, All Types, Staphylococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3700.