SPQ(TM) TEST SYSTEM FOR PREALBUMIN— 510(k) K884297

Name: FDA 510(k) clearance K884297
Creator: U.S. Food and Drug Administration
Published: 1988-11-02

Substantially Equivalent

Atlantic Antibodies

FDA 510(k) clearance K884297 for SPQ(TM) TEST SYSTEM FOR PREALBUMIN, Substantially Equivalent on 1988-11-02. Applicant: Atlantic Antibodies. Device class: 1.

Clearance details

Applicant: Atlantic Antibodies
Product code: Code JZJ
Device class: Class 1
Regulation: 21 CFR 866.5060
Advisory panel: Immunology
Date received: 1988-10-12
Decision date: 1988-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JZJ

view all

K000661 — RANDOX PREALBUMIN2000-04-13
K972638 — TINA-QUANT PREALBUMIN1998-01-09
K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT1995-06-01
K913672 — PREALBUMIN IMMUNOLOGICAL NL TEST KIT1991-12-20
K884298 — SPQ(TM) TEST SYSTEM FOR MICROALBUMIN1988-11-02

More clearances from Atlantic Antibodies

view all

K892526 — SPQ TM TEST SYSTEM II FOR CRP1989-05-09
K891154 — SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B1989-03-16
K890563 — SPQ(TM) ANTIBODY REAGENT SET II FOR TRF1989-03-03
K890561 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGM1989-02-23
K890416 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGG1989-02-22

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