S/P SURE-CAP C— 510(k) K812922

Substantially Equivalent

American Dade

FDA 510(k) clearance K812922 for S/P SURE-CAP C, Substantially Equivalent on 1981-11-06. Applicant: American Dade. Device class: 1.

Clearance details

Applicant: American Dade
Product code: Code GIO
Device class: Class 1
Regulation: 21 CFR 864.6150
Advisory panel: Hematology
Date received: 1981-10-19
Decision date: 1981-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GIO

K972969 — QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM1997-09-22
K941291 — MONOJECT SAMPLETTE SEPARATOR TUBE1994-10-27
K894851 — TRU-TRAX1989-09-29
K885324 — HEMA(PRO)TEC(TION)1989-02-17
K885138 — CAPILLARY TUBE, BLOOD COLLECTION1989-02-07

More clearances from American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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