FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHLAMYDIA & VIRAL TRANSPORT MEDIUM
K Number: K871065
·
Decision Apr 14, 1987
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
12
Review Days
27
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Basic Information
- Device Name
- CHLAMYDIA & VIRAL TRANSPORT MEDIUM
- K Number
- K871065
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- R. Kent Richards, Inc.
- Date Received
- March 18, 1987
- Decision Date
- April 14, 1987
- Product Code
- JSM
- 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 |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | FDA class 1 | Microbiology |
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Other Clearances by R. Kent Richards, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854452 | MANNITOL SALT AGAR | Nov 18, 1985 | Substantially Equivalent |
| K854456 | CAMPYLOBACTER BLOOD AGAR | Nov 18, 1985 | Substantially Equivalent |
| K854455 | CDC ANAEROBE BLOOD AGAR | Nov 18, 1985 | Substantially Equivalent |
| K854454 | TRYPTIC SOY BLOOD AGAR | Nov 18, 1985 | Substantially Equivalent |
| K854457 | COLUMBIA CNA AGAR W/5% SHEEP BLOOD | Nov 18, 1985 | Substantially Equivalent |
| K854449 | HEKTOEN ENTERIC AGAR | Nov 18, 1985 | Substantially Equivalent |
| K854453 | P.E.Z. AGAR (PHENYLETHANOL AGAR) | Nov 18, 1985 | Substantially Equivalent |
| K854450 | BILE ESCULIN AZIDE AGAR | Nov 18, 1985 | Substantially Equivalent |
| K854451 | MUELLER HINTON MEDIUM | Nov 18, 1985 | Substantially Equivalent |
| K854275 | THAYER-MARTIN MEDIUM (MOD) | Nov 12, 1985 | Substantially Equivalent |