510(k) K811263
- Device
- TOX TM ANALYZER
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K811263
- Product code
- JQZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-29
- Date received
- 1981-05-06
- Regulation
- 862.2050
- Classification name
- Polarimeter
- Medical specialty
- Clinical Chemistry
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 8030433
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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