FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEXTOEN ENTERIC AGAR
K Number: K800980
·
Decision May 23, 1980
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
11
Review Days
30
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
- HEXTOEN ENTERIC AGAR
- K Number
- K800980
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Quality Assurance Laboratory, Inc.
- Date Received
- April 23, 1980
- Decision Date
- May 23, 1980
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSI), ordered by most recent decision date.
BBL CHROMAGAR 0157
FDA 510(k)
FDA Class 1
·Microbiology
DIPSTREAK
FDA 510(k)
FDA Class 1
·Microbiology
LISTERIA SELECTIVE ENRICHMENT MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
DENTOCULT SM-STRIP MUTANS
FDA 510(k)
FDA Class 1
·Microbiology
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326
FDA 510(k)
FDA Class 1
·Microbiology
MODIFIED SELECTIVE STREPTOCOCCUS AGAR
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| 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 |
| K800982 | SALMONELLA SHIGELLA AGAR | May 23, 1980 | Substantially Equivalent |