510(k) K920974
- Device
- BACTIDROP ACRIDINE ORANGE
- Applicant
- REMEL CO.
- 510(k) number
- K920974
- Product code
- JFO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-06-19
- Date received
- 1992-03-02
- Regulation
- 862.1145
- Classification name
- Fluorometric, Calcium
- Medical specialty
- Clinical Chemistry
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANN SILVIUS
- Address
- 12076 Santa Fe Dr. Lenexa KS US 66215 66215
FDA Registration Numbers#
- 3006198300
- 2431530
- 3037000637
- 1924669
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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