Home / 510(k) Clearances / K070757

510(k) K070757

MICROPROTEIN REAGENT SET by Pointe Scientific, Inc., — Product Code JGP

K070757 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "MICROPROTEIN REAGENT SET". The FDA issued a decision of Substantially Equivalent on December 4, 2007. The device falls under product code JGP (Lowry (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Pointe Scientific, Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2007
Date Received
March 20, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lowry (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

Other clearances by Pointe Scientific, Inc.,

  • K062118 — POINTE 360 (July 13, 2007)
  • K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT (April 30, 2007)
  • K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR (April 13, 2007)
  • K070504 — AMMONIA/ALCOHOL CONTROL SET (April 11, 2007)
  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (March 28, 2007)
  • K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (October 7, 2005)
  • K040391 — TOTAL BILIRUBIN REAGENT SET (June 2, 2004)
  • K031539 — HEMOGLOBIN A1C REAGENT SET (August 6, 2003)
  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (April 28, 2003)
  • K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (March 31, 2003)

Other clearances for product code JGP

  • K964960 — VITROS CHEMISTRY PRODUCTS UPRO SLIDES (February 18, 1997)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K821534 — HEMATOLOGY DATA MANAGEMENT SYS (June 10, 1982)
  • K792347 — MICRO LOWRY PROTEINTEST (December 6, 1979)

FDA data resources