FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THAYER-MARTIN AGAR
K Number: K800977
·
Decision May 23, 1980
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
82
Applicant Total
11
Review Days
30
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Basic Information
- Device Name
- THAYER-MARTIN AGAR
- K Number
- K800977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2410
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Quality Assurance Laboratory, Inc.
- Date Received
- April 23, 1980
- Decision Date
- May 23, 1980
- Product Code
- JTY
- 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 |
|---|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | FDA class 2 | 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 |
| K800981 | CHOCOLATE AGAR W/ENRICHMENTS | May 28, 1980 | Substantially Equivalent |
| K800978 | XYLOSE LYSINE DESOXYCHOLATE AGAR | May 28, 1980 | Substantially Equivalent |
| K800985 | THIOGLYCOLLATE MED. W/O INDICATOR | 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 |