FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYCOSEL AGAR
K Number: K832582
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
13
Review Days
41
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Basic Information
- Device Name
- MYCOSEL AGAR
- K Number
- K832582
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Acuderm, Inc.
- Date Received
- August 2, 1983
- Decision Date
- September 12, 1983
- 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
Other 510(k) clearances with the same product code (JSJ), ordered by most recent decision date.
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Other Clearances by Acuderm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933516 | ACU-E PUNCH | Mar 24, 1994 | Substantially Equivalent |
| K933265 | ACU-DISPO-CE(TM) | Mar 7, 1994 | Substantially Equivalent |
| K933137 | ACU-SUTURE KIT | Feb 22, 1994 | Substantially Equivalent |
| K930043 | ACU-EVAC | Feb 9, 1994 | Substantially Equivalent |
| K933866 | ACU-HEMOSTATIC RING | Dec 1, 1993 | Substantially Equivalent |
| K915000 | ACU-GUARD | Jan 27, 1992 | Substantially Equivalent |
| K891334 | ACU-CURETTE | Apr 11, 1989 | Substantially Equivalent |
| K874024 | ACU-MICRO-NEEDLE | Nov 23, 1987 | Substantially Equivalent |
| K854877 | ACU-SYRINGE W/WO NEEDLES | Feb 19, 1986 | Substantially Equivalent |
| K832583 | SABOURAUD DEXTROSE AGAR | Sep 12, 1983 | Substantially Equivalent |