FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APL GN BROTH
K Number: K853613
·
Decision Sep 6, 1985
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
25
Review Days
8
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Basic Information
- Device Name
- APL GN BROTH
- K Number
- K853613
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Apl Medical Supplies
- Date Received
- August 29, 1985
- Decision Date
- September 6, 1985
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
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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 |
| K853612 | APL DNASE TEST AGAR | Sep 6, 1985 | Substantially Equivalent |
| K853616 | APL CHLAMYDOSPORE AGAR | Sep 6, 1985 | Substantially Equivalent |