Product code JGP— Clinical Chemistry

HEMATOLOGY DATA MANAGEMENT SYS

Classification name: Lowry (Colorimetric), Total Protein
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Total cleared: 5
First cleared: 1979-12-06
Most recent: 2007-12-04

Market context for product code JGP

FDA has cleared 5 devices under product code JGP between 1979 and 2007, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20071 clearance
19971 clearance
19861 clearance
19821 clearance
19791 clearance

Top applicants under product code JGP

Pointe Scientific, Inc.,1 clearance
Panmed, Inc.1 clearance
Johnson & Johnson Clinical Diagnostics, Inc.1 clearance
J. D. Assoc.1 clearance
Biovation, Inc.1 clearance

Recent clearances under product code JGP

K070757 — MICROPROTEIN REAGENT SETPointe Scientific, Inc.,·2007-12-04
K964960 — VITROS CHEMISTRY PRODUCTS UPRO SLIDESJohnson & Johnson Clinical Diagnostics, Inc.·1997-02-18
K863112 — PROTEINMETERJ. D. Assoc.·1986-12-10
K821534 — HEMATOLOGY DATA MANAGEMENT SYSBiovation, Inc.·1982-06-10
K792347 — MICRO LOWRY PROTEINTESTPanmed, Inc.·1979-12-06

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