FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTITATIVE DETERMINATION OF PORPHYRINS
K Number: K780455
·
Decision Jul 27, 1978
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
3
Review Days
129
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- QUANTITATIVE DETERMINATION OF PORPHYRINS
- K Number
- K780455
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1595
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Whale Scientific, Inc.
- Date Received
- March 20, 1978
- Decision Date
- July 27, 1978
- Product Code
- JKJ
- 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 |
|---|---|---|---|
| JKJ | Fluorometric Measurement, Porphyrins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JKJ), ordered by most recent decision date.
PROTOFLUOR Z
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROTOFLUOR Z
FDA 510(k)
FDA Class 1
·Clinical Chemistry