510(k) K843612
- Device
- MODIFICATION OF ABL MIC-10 PRECEPT SYS
- Applicant
- AUSTIN BIOLOGICAL LABORATORIES
- 510(k) number
- K843612
- Product code
- LTD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-02-19
- Date received
- 1984-09-13
- Regulation
- 510(k) Premarket Notification
- Classification name
- Paraquat Assay
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Microbiology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- REX L BRADLEY
- Address
- 6620 Manor Rd. Austin TX US 78723 78723
FDA Registration Numbers#
- 3031582440
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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