FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD
K Number: K851591
·
Decision May 13, 1985
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
28
Review Days
27
Basic Information
- Device Name
- PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD
- K Number
- K851591
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- PREFERRED MICRO-MEDIA
- Date Received
- April 16, 1985
- Decision Date
- May 13, 1985
- Product Code
- JSJ
- 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | FDA class 1 | Microbiology |
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Other Clearances by PREFERRED MICRO-MEDIA
| K Number | Device Name | ||
|---|---|---|---|
| K851594 | SF BROTH | May 14, 1985 | Substantially Equivalent |
| K851596 | SIM MEDIUM | May 13, 1985 | Substantially Equivalent |
| K851595 | SIMMONS CITRATE AGAR | May 13, 1985 | Substantially Equivalent |
| K851597 | TRIPLE SUGAR IRON AGAR | May 13, 1985 | Substantially Equivalent |
| K851592 | SABOURAUD DEXTROSE AGAR | May 13, 1985 | Substantially Equivalent |
| K851593 | SELECTIVE STREPTOCOCCUS AGAR | May 13, 1985 | Substantially Equivalent |
| K851598 | THIOGLYCOLLATE WITHOUT INDICATOR | May 10, 1985 | Substantially Equivalent |
| K851576 | BIGGY AGAR NICKERSONS MEDIUM | May 9, 1985 | Substantially Equivalent |
| K851577 | BILE ESCULIN AZIDE AGAR | May 8, 1985 | Substantially Equivalent |
| K851601 | TRYPTIC SOY BROTH | May 8, 1985 | Substantially Equivalent |