DELFIA (TM) HCG KIT— 510(k) K862044
Substantially EquivalentLkb Instruments, Inc.
FDA 510(k) clearance K862044 for DELFIA (TM) HCG KIT, Substantially Equivalent on 1986-07-11. Applicant: Lkb Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Lkb Instruments, Inc.
- Product code
- Code JHJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
Recent devices under product code JHJ
view allMore clearances from Lkb Instruments, Inc.
view allRecalls naming K862044
K-number listed on FDA's recall record- Z-1237-2019 — DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
- Z-1238-2019 — AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
- Z-1239-2019 — AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K862044.
Data sourced from openFDA. This site is unofficial and independent of the FDA.