FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
TRYPTONE WATER (1%)
K Number: K864256
·
Decision Mar 31, 1987
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
86
Applicant Total
21
Review Days
154
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Basic Information
- Device Name
- TRYPTONE WATER (1%)
- K Number
- K864256
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Mds Laboratories, Inc.
- Date Received
- October 28, 1986
- Decision Date
- March 31, 1987
- 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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FDA 510(k)
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Other Clearances by Mds Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864251 | SELENITE F. BROTH | Mar 31, 1987 | Substantially Equivalent |
| K864255 | TRYPTICASE SOY BROTH | Mar 31, 1987 | Substantially Equivalent |
| K864238 | CHOCOLATE AGAR | Mar 31, 1987 | Substantially Equivalent |
| K864240 | COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD | Mar 31, 1987 | Substantially Equivalent |
| K864241 | DNASE AGAR | Mar 31, 1987 | Substantially Equivalent |
| K864244 | GARNERELLA VAGINALIS IDENTIFICATION KIT | Mar 31, 1987 | Substantially Equivalent |
| K864239 | CLED AGAR WITH ANDRADES INDICATOR | Mar 31, 1987 | Substantially Equivalent |
| K864254 | THIOGLYCOLLATE BROTH | Mar 31, 1987 | Substantially Equivalent |
| K864237 | CARY BLAIR TRANSPORT MEDIUM | Mar 31, 1987 | Substantially Equivalent |
| K864246 | MUELLER HINTON AGAR LARGE | Mar 31, 1987 | Substantially Equivalent |