FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLATE, LD PRESUMPTO
K Number: K781856
·
Decision Nov 22, 1978
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
52
Applicant Total
52
Review Days
16
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PLATE, LD PRESUMPTO
- K Number
- K781856
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Anaerobe Systems
- Date Received
- November 6, 1978
- Decision Date
- November 22, 1978
- Product Code
- JSE
- 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 |
|---|---|---|---|
| JSE | Culture Media, Multiple Biochemical Test | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSE), ordered by most recent decision date.
MLX MICROTITER PLATE LUMINOMETER
FDA 510(k)
FDA Class 1
·Microbiology
X-ACT UREA/TDA
FDA 510(k)
FDA Class 1
·Microbiology
X-ACT LDC/IND
FDA 510(k)
FDA Class 1
·Microbiology
MIL MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
MRVP BROTH
FDA 510(k)
FDA Class 1
·Microbiology
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Anaerobe Systems
| K Number | Device Name | ||
|---|---|---|---|
| K844381 | COLISTIN 10 MCG. DIFFERENTIAL DISK | Jan 4, 1985 | Substantially Equivalent |
| K844382 | VANCOMYCIN 5MCG DIFFERENTIAL DISK | Jan 4, 1985 | Substantially Equivalent |
| K844383 | KANAMYCIN 1000 MCG DIFFERENTIAL DISK | Jan 4, 1985 | Substantially Equivalent |
| K844380 | BILE DIFFERENTIAL DISK | Jan 4, 1985 | Substantially Equivalent |
| K841303 | CAMPYLOBACTER THIOGLYCOLLATE MED | Apr 17, 1984 | Substantially Equivalent |
| K841218 | CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR | Apr 5, 1984 | Substantially Equivalent |
| K841142 | LEVINE EOSIN METHYLENE BLUE AGAR | Apr 5, 1984 | Substantially Equivalent |
| K841221 | BRAIN HEART INFUSION BROTH | Apr 4, 1984 | Substantially Equivalent |
| K841220 | ANAEROBIC TRANSPORT MEDIUM | Apr 4, 1984 | Substantially Equivalent |
| K841222 | BACTEROIDES BILE ESCULIN GAR | Apr 4, 1984 | Substantially Equivalent |