BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST— 510(k) K012521
Substantially EquivalentBinax, Inc.
FDA 510(k) clearance K012521 for BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST, Substantially Equivalent on 2001-11-30. Applicant: Binax, Inc.. Device class: 1.
Clearance details
- Applicant
- Binax, Inc.
- 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
- Portland, ME, US
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- K971522 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
- K962060 — STREP A OIA MAX
More clearances from Binax, Inc.
view allRecalls naming K012521
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012521.
Data sourced from openFDA. This site is unofficial and independent of the FDA.