STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I— 510(k) K001976
Substantially EquivalentOraSure Technologies, Inc.
FDA 510(k) clearance K001976 for STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I, Substantially Equivalent on 2000-12-06. Applicant: OraSure Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- OraSure Technologies, Inc.
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
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More clearances from OraSure Technologies, Inc.
view allRecalls naming K001976
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 K001976.
Data sourced from openFDA. This site is unofficial and independent of the FDA.