510(k) K791979
- Device
- TECHNICON FAST-LC SYS. ANTICONVU DRUGS
- Applicant
- TECHNICON INSTRUMENTS CORP.
- 510(k) number
- K791979
- Product code
- DPE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-11-13
- Date received
- 1979-09-25
- Regulation
- 862.3350
- Classification name
- Thin Layer Chromatography, Diphenylhydantoin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents
510(k) summary PDF not indicated by FDA
Legacy Summary
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FDA Review
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