FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MCBRIDE MEDIUM CM 819
K Number: K872135
·
Decision Jun 15, 1987
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
93
Review Days
12
Basic Information
- Device Name
- MCBRIDE MEDIUM CM 819
- K Number
- K872135
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- OXOID U.S.A., INC.
- Date Received
- June 3, 1987
- Decision Date
- June 15, 1987
- Product Code
- JSJ
- 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | FDA class 1 | Microbiology |
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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 |
| K870945 | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 | Jun 10, 1987 | Substantially Equivalent |
| K862946 | OXOID SIGNAL BLOOD CULTURE SYSTEM | Nov 5, 1986 | Substantially Equivalent |
| K855234 | DIAGNOSTIC REAGENT VET-RPLA | Nov 4, 1986 | Substantially Equivalent |
| K855236 | DIAGNOSTIC REAGENT TST-RPLA | Nov 4, 1986 | Substantially Equivalent |
| K855235 | DIAGNOSTIC REAGENT PET-RPLA | Nov 4, 1986 | Substantially Equivalent |