FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SELECTIVE STREPTOCOCCUS AGAR
K Number: K851593
·
Decision May 13, 1985
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
28
Review Days
27
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Basic Information
- Device Name
- SELECTIVE STREPTOCOCCUS AGAR
- K Number
- K851593
- 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 |
Similar 510(k) Clearances
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FDA 510(k)
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Other Clearances by Preferred Micro-Media
| K Number | Device Name | ||
|---|---|---|---|
| K851594 | SF BROTH | May 14, 1985 | Substantially Equivalent |
| K851597 | TRIPLE SUGAR IRON AGAR | May 13, 1985 | Substantially Equivalent |
| K851591 | PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD | May 13, 1985 | Substantially Equivalent |
| K851592 | SABOURAUD DEXTROSE AGAR | May 13, 1985 | Substantially Equivalent |
| K851595 | SIMMONS CITRATE AGAR | May 13, 1985 | Substantially Equivalent |
| K851596 | SIM MEDIUM | May 13, 1985 | Substantially Equivalent |
| K851598 | THIOGLYCOLLATE WITHOUT INDICATOR | May 10, 1985 | Substantially Equivalent |
| K851576 | BIGGY AGAR NICKERSONS MEDIUM | May 9, 1985 | Substantially Equivalent |
| K851599 | TRICHOMONAS BROTH (KUPFORBERG | May 8, 1985 | Substantially Equivalent |
| K851600 | TRYPTIC SOY AGAR W/5% SHEEP BLOOD | May 8, 1985 | Substantially Equivalent |