FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HIPP MICROTUBE
K Number: K812470
·
Decision Sep 14, 1981
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
86
Applicant Total
6
Review Days
14
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Basic Information
- Device Name
- HIPP MICROTUBE
- K Number
- K812470
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Carr Microbiologicals
- Date Received
- August 31, 1981
- Decision Date
- September 14, 1981
- Product Code
- JSF
- 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 |
|---|---|---|---|
| JSF | Culture Media, Single Biochemical Test | FDA class 1 | Microbiology |
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Other Clearances by Carr Microbiologicals
| K Number | Device Name | ||
|---|---|---|---|
| K812469 | RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB | Sep 14, 1981 | Substantially Equivalent |
| K812465 | PHOS MICROTUBES | Sep 14, 1981 | Substantially Equivalent |
| K812468 | PYRR MICROTUBE | Sep 14, 1981 | Substantially Equivalent |
| K812466 | ONPX-INDOL MEDIUM MICROTUBES | Sep 14, 1981 | Substantially Equivalent |
| K812467 | PGUA-INDOL MICROTUBE | Sep 14, 1981 | Substantially Equivalent |