FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CYSTINE TRYPTIC AGAR W/DEXTROSE
K Number: K844542
·
Decision Jan 16, 1985
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
86
Applicant Total
251
Review Days
56
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Basic Information
- Device Name
- CYSTINE TRYPTIC AGAR W/DEXTROSE
- K Number
- K844542
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- bioMerieux, Inc.
- Date Received
- November 21, 1984
- Decision Date
- January 16, 1985
- Product Code
- JSF
- 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 |
|---|---|---|---|
| JSF | Culture Media, Single Biochemical Test | FDA class 1 | Microbiology |
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