FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NICKERSON'S MED. SELECTIVE CULTURE MEDIU
K Number: K800754
·
Decision Apr 29, 1980
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
9
Review Days
25
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Basic Information
- Device Name
- NICKERSON'S MED. SELECTIVE CULTURE MEDIU
- K Number
- K800754
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ortho Pharmaceutical Corp.
- Date Received
- April 4, 1980
- Decision Date
- April 29, 1980
- 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 |
Similar 510(k) Clearances
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Other Clearances by Ortho Pharmaceutical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955648 | K-Y PERSONAL LUBRICANT | Jun 21, 1996 | Substantially Equivalent |
| K934516 | ADVANCE PREGNANCY TEST MODIFICATION | Feb 24, 1994 | Substantially Equivalent |
| K914990 | ADVANCE(R) PREGNANCY TEST | Dec 23, 1991 | Substantially Equivalent |
| K893488 | PULSATILE PUMP FOR GONADORELIN ACETATE | Oct 31, 1989 | Substantially Equivalent |
| K881151 | MICROSCRAPE | Apr 6, 1988 | Substantially Equivalent |
| K810581 | FACT* HOME PREGNANCY TEST | Mar 17, 1981 | Substantially Equivalent |
| K792634 | CONCEPTROL/THIN PROPHYLACTICS | Jan 16, 1980 | Substantially Equivalent |
| K790087 | LUBRICANT, OTRHO PERSONAL | Feb 1, 1979 | Substantially Equivalent |