EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229— 510(k) K011605
Substantially EquivalentSyva Co., Dade Behring, Inc.
FDA 510(k) clearance K011605 for EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229, Substantially Equivalent on 2001-06-12. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Syva Co., Dade Behring, Inc.
- Product code
- Code LBZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code LBZ
view allMore clearances from Syva Co., Dade Behring, Inc.
view all- K011920 — EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
- K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
- K011300 — EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
- K011306 — EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
- K011161 — MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
Recalls naming K011605
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 K011605.
Data sourced from openFDA. This site is unofficial and independent of the FDA.