510(k) K870214
- Device
- MODIFIED SALTEX REAGENT STRIPS
- Applicant
- MILES LABORATORIES, INC.
- 510(k) number
- K870214
- Product code
- CHK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-29
- Date received
- 1987-01-20
- Regulation
- 862.1170
- Classification name
- Mercuric Nitrate And Diphenyl Carbazone (titrimetric), Chloride
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN H ENGELMANN
- Address
- 1127 Myrtle St. P.O. Box 40 Elkhart IN US 46514 46514
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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