FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HAEMOPHILUS TEST MEDIUM (HTM)
K Number: K952595
·
Decision Apr 10, 1996
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
39
Applicant Total
2
Review Days
309
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Basic Information
- Device Name
- HAEMOPHILUS TEST MEDIUM (HTM)
- K Number
- K952595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Clinical Standards Laboratories, Inc.
- Date Received
- June 6, 1995
- Decision Date
- April 10, 1996
- Product Code
- JSO
- 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 |
|---|---|---|---|
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | FDA class 2 | Microbiology |
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Other Clearances by Clinical Standards Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941111 | STREP-SURE A/E | Aug 2, 1994 | Substantially Equivalent |