FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOCOLATE AGAR W/ENRICHMENTS
K Number: K800981
·
Decision May 28, 1980
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
208
Applicant Total
11
Review Days
35
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Basic Information
- Device Name
- CHOCOLATE AGAR W/ENRICHMENTS
- K Number
- K800981
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Quality Assurance Laboratory, Inc.
- Date Received
- April 23, 1980
- Decision Date
- May 28, 1980
- Product Code
- JSG
- 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | FDA class 1 | Microbiology |
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Other Clearances by Quality Assurance Laboratory, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K800987 | MUELLER HINTON AGAR | Jun 2, 1980 | Substantially Equivalent |
| K800986 | TRYPTICASE SOY AGAR W5% SHEEP BLOOD | Jun 2, 1980 | Substantially Equivalent |
| K800978 | XYLOSE LYSINE DESOXYCHOLATE AGAR | May 28, 1980 | Substantially Equivalent |
| K800985 | THIOGLYCOLLATE MED. W/O INDICATOR | May 23, 1980 | Substantially Equivalent |
| K800977 | THAYER-MARTIN AGAR | May 23, 1980 | Substantially Equivalent |
| K800983 | MACCONKEY AGAR | May 23, 1980 | Substantially Equivalent |
| K800979 | MUELLER HINTIN AGAR W/5% SHEEP BLOOD | May 23, 1980 | Substantially Equivalent |
| K800984 | EOSIN METHYLENE BLUE AGAR, LEVINE | May 23, 1980 | Substantially Equivalent |
| K800980 | HEXTOEN ENTERIC AGAR | May 23, 1980 | Substantially Equivalent |
| K800982 | SALMONELLA SHIGELLA AGAR | May 23, 1980 | Substantially Equivalent |