TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY— 510(k) K930810

Name: FDA 510(k) clearance K930810
Creator: U.S. Food and Drug Administration
Published: 1994-01-11

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K930810 for TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY, Substantially Equivalent on 1994-01-11. Applicant: Hybritech, Inc.. Device class: 2.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code CIN
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1993-02-17
Decision date: 1994-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIN

view all

K232904 — Access Ostase2024-04-15
K200475 — IDS-iSYS Ostase BAP2020-09-30
K043125 — ORION DIAGNOSTICA UNIQ PINP RIA2005-05-04
K020625 — SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 33462002-05-06
K011113 — HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)2001-06-13

More clearances from Hybritech, Inc.

view all

K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY1997-09-11
K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY1996-08-19
K922754 — TANDEM-E IGE II CALIBRATION VERIFICATION SET1993-02-17
K921745 — HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO1992-07-30
K920556 — TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET1992-07-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.