FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAXIMUM RECOVERY DILUENT
K Number: K841662
·
Decision Jun 7, 1984
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
208
Applicant Total
93
Review Days
45
Basic Information
- Device Name
- MAXIMUM RECOVERY DILUENT
- K Number
- K841662
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- OXOID U.S.A., INC.
- Date Received
- April 23, 1984
- Decision Date
- June 7, 1984
- Product Code
- JSG
- 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 |
|---|---|---|---|
| JSG | Culture Media, Non-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 |
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| 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 |
| K855234 | DIAGNOSTIC REAGENT VET-RPLA | Nov 4, 1986 | Substantially Equivalent |
| K855236 | DIAGNOSTIC REAGENT TST-RPLA | Nov 4, 1986 | Substantially Equivalent |