FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIAGNOSTIC REAGENT SET-RPLA
K Number: K855233
·
Decision Nov 4, 1986
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
3
Applicant Total
93
Review Days
308
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Basic Information
- Device Name
- DIAGNOSTIC REAGENT SET-RPLA
- K Number
- K855233
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Oxoid U.S.A., Inc.
- Date Received
- December 31, 1985
- Decision Date
- November 4, 1986
- Product Code
- GTN
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GTN | Antisera, Fluorescent, All Types, Staphylococcus Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GTN), ordered by most recent decision date.
DIAGNOSTIC REAGENT TST-RPLA
FDA 510(k)
FDA Class 1
·Microbiology
STAPHAUREX ZL30
FDA 510(k)
FDA Class 1
·Microbiology
AGGLUTINOTEST-STAPHYLOLISIN
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Oxoid U.S.A., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K891593 | LISTERIA SELECTIVE ENRICHMENT MEDIUM | Jun 9, 1989 | Substantially Equivalent |
| K884026 | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT | Feb 3, 1989 | Substantially Equivalent |
| K884208 | LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) | Oct 25, 1988 | Substantially Equivalent |
| K874303 | STAPHYLASE TEST | Nov 6, 1987 | Substantially Equivalent |
| K872956 | SORBITOL MACCONKEY AGAR NO. 3 CM 813 | Aug 10, 1987 | Substantially Equivalent |
| K872135 | MCBRIDE MEDIUM CM 819 | Jun 15, 1987 | Substantially Equivalent |
| K870945 | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 | Jun 10, 1987 | Substantially Equivalent |
| K862946 | OXOID SIGNAL BLOOD CULTURE SYSTEM | Nov 5, 1986 | Substantially Equivalent |
| K855236 | DIAGNOSTIC REAGENT TST-RPLA | Nov 4, 1986 | Substantially Equivalent |
| K855234 | DIAGNOSTIC REAGENT VET-RPLA | Nov 4, 1986 | Substantially Equivalent |