FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
CALCIUM REAGENT-METHYL THYMOL BLUE METHOD
K Number: K870369
·
Decision Aug 19, 1987
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
4
Applicant Total
55
Review Days
203
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Basic Information
- Device Name
- CALCIUM REAGENT-METHYL THYMOL BLUE METHOD
- K Number
- K870369
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Trace Scientific , Ltd.
- Date Received
- January 28, 1987
- Decision Date
- August 19, 1987
- Product Code
- CIA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CIA | Methylthymol Blue, Calcium | FDA class 2 | Clinical Chemistry |
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| K932713 | TRACE TRANSFERRIN REAGENT | Sep 30, 1993 | Substantially Equivalent |
| K923322 | TRACE ALBUMIN-MR REAGENT | Sep 11, 1992 | Substantially Equivalent |
| K914731 | TRACE GAMMA GT-SS REAGENT | Nov 19, 1991 | Substantially Equivalent |
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