IMMULITE ESTRADIOL— 510(k) K932926
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K932926 for IMMULITE ESTRADIOL, Substantially Equivalent on 1994-01-10. Applicant: Diagnostic Products Corp.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code CHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code CHP
view all- K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
- K973901 — 17 B-ESTRADIOL (ELISA)
- K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- K970386 — ACS ESTADIOL-6 II
- K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
More clearances from Diagnostic Products Corp.
view all- K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
- K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
- K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
- K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
- K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE
Recalls naming K932926
K-number listed on FDA's recall record- Z-1242-2016 — IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal sexual disorders
- Z-1243-2016 — IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932926.
Data sourced from openFDA. This site is unofficial and independent of the FDA.