ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II— 510(k) K971522
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K971522 for ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II, Substantially Equivalent on 1998-03-03. Applicant: Abbott Laboratories. Device class: 1.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code GTZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbott Park, IL, US
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More clearances from Abbott Laboratories
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