FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOSATE
K Number: K811730
·
Decision Jul 2, 1981
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
69
Applicant Total
177
Review Days
14
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Basic Information
- Device Name
- BIOSATE
- K Number
- K811730
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2450
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Acumedia Manufacturers, Inc.
- Date Received
- June 18, 1981
- Decision Date
- July 2, 1981
- Product Code
- JSK
- 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 |
|---|---|---|---|
| JSK | Supplement, Culture Media | FDA class 1 | Microbiology |
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Other Clearances by Acumedia Manufacturers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881538 | ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR | Apr 18, 1988 | Substantially Equivalent |
| K881565 | INHIBITORY MOLD AGAR | Apr 18, 1988 | Substantially Equivalent |
| K881543 | LETHEEN AGAR | Apr 18, 1988 | Substantially Equivalent |
| K881540 | FLO AGAR | Apr 18, 1988 | Substantially Equivalent |
| K881536 | ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR | Apr 18, 1988 | Substantially Equivalent |
| K881542 | HEART INFUSION AGAR | Apr 18, 1988 | Substantially Equivalent |
| K881571 | YM BROTH | Apr 18, 1988 | Substantially Equivalent |
| K881541 | GELATIN | Apr 18, 1988 | Substantially Equivalent |
| K881554 | SKIM MILK DEHYDRATED | Apr 18, 1988 | Substantially Equivalent |
| K881577 | MODIFIED SELECTIVE STREPTOCOCCUS AGAR | Apr 18, 1988 | Substantially Equivalent |