FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APL MUELLER HINTON AGAR
K Number: K853238
·
Decision Aug 19, 1985
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
73
Applicant Total
25
Review Days
18
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Basic Information
- Device Name
- APL MUELLER HINTON AGAR
- K Number
- K853238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Apl Medical Supplies
- Date Received
- August 1, 1985
- Decision Date
- August 19, 1985
- Product Code
- JTZ
- 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 |
|---|---|---|---|
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JTZ), ordered by most recent decision date.
MUELLER HINTON AGAR
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MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
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MUELLER HINTON AGAR WITH 2% NACI
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CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
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·Microbiology
MUELLER HINTON AGAR W/OXACILLIN
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Other Clearances by Apl Medical Supplies
| K Number | Device Name | ||
|---|---|---|---|
| K853610 | APL MOTILITY INDOLE ORNITHINE AGAR | Sep 16, 1985 | Substantially Equivalent |
| K853617 | APL SIMMONS CITRATE AGAR | Sep 16, 1985 | Substantially Equivalent |
| K853618 | APL SIM MEDIUM | Sep 16, 1985 | Substantially Equivalent |
| K853619 | APL TRIPLE SUGAR IRON AGAR | Sep 16, 1985 | Substantially Equivalent |
| K853611 | APL XYLOSE LYSINE DEOXYCHOLATE AGAR | Sep 12, 1985 | Substantially Equivalent |
| K853609 | APL TRYPTIC SOY BROTH | Sep 12, 1985 | Substantially Equivalent |
| K853614 | APL FLUID THIOGLYCOLLATE MEDIUM | Sep 6, 1985 | Substantially Equivalent |
| K853615 | APL BILE ESCULIN/AZIDE AGAR | Sep 6, 1985 | Substantially Equivalent |
| K853613 | APL GN BROTH | Sep 6, 1985 | Substantially Equivalent |
| K853612 | APL DNASE TEST AGAR | Sep 6, 1985 | Substantially Equivalent |