FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AEROMONAS AGAR(XDCA)
K Number: K852789
·
Decision Jul 19, 1985
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
67
Review Days
18
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Basic Information
- Device Name
- AEROMONAS AGAR(XDCA)
- K Number
- K852789
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Gibco Laboratories Life Technologies, Inc.
- Date Received
- July 1, 1985
- Decision Date
- July 19, 1985
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by Gibco Laboratories Life Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871855 | SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM | May 26, 1987 | Substantially Equivalent |
| K871541 | MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 | Apr 29, 1987 | Substantially Equivalent |
| K870134 | MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE | Feb 4, 1987 | Substantially Equivalent |
| K864755 | PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM | Jan 5, 1987 | Substantially Equivalent |
| K864014 | LOMBARD DOWELL AGAR BASE | Oct 29, 1986 | Substantially Equivalent |
| K863821 | MUELLER HINTON AGAR W/4%NACL AND OXACILLIN | Oct 9, 1986 | Substantially Equivalent |
| K863820 | DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300 | Oct 8, 1986 | Substantially Equivalent |
| K863289 | CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN | Sep 3, 1986 | Substantially Equivalent |
| K862425 | MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM | Jul 2, 1986 | Substantially Equivalent |
| K861058 | SENSITITRE AUTO ID PLATE, AP70 | May 20, 1986 | Substantially Equivalent |