DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET— 510(k) K881773

Name: FDA 510(k) clearance K881773
Creator: U.S. Food and Drug Administration
Published: 1988-06-10

Substantially Equivalent

Casco Standards

FDA 510(k) clearance K881773 for DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET, Substantially Equivalent on 1988-06-10. Applicant: Casco Standards. Device class: 1.

Clearance details

Applicant: Casco Standards
Product code: Code JJR
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1988-04-26
Decision date: 1988-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yarmouth, ME, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJR

view all

K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 28161999-04-27
K960592 — ELECTROLYTE STANDARDS1996-05-13
K955630 — RNA MEDICAL HEMAT CONTROL1996-03-01
K951435 — AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL1995-05-02
K943925 — SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING1994-10-04

More clearances from Casco Standards

view all

K981436 — DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-1091998-04-24
K972904 — DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL1998-02-20
K962629 — DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR1996-09-13
K961750 — DOCUMENT CARDIAC ASSAYED CONTROL1996-07-22
K962630 — DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL1996-07-22

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