510(k) K850680
- Device
- ENCORE FERRITIN REAGENT
- Applicant
- HYBRITECH, INC.
- 510(k) number
- K850680
- Product code
- JMB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-21
- Date received
- 1985-02-21
- Regulation
- 864.7360
- Classification name
- Visual, Semi-quant. (colorimetric), Glucose-6-phosphate Dehydrogenase
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN F BRUNI
- Address
- 11095 Torreyana Rd. P.O. Box 269006 San Diego CA US 92126 92126
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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