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510(k) K842772

PHARMACIA B2-MICRO RIA by Pharmacia, Inc. — Product Code JGZ

K842772 is an FDA 510(k) premarket notification submitted by Pharmacia, Inc. for the device "PHARMACIA B2-MICRO RIA". The FDA issued a decision of Substantially Equivalent on November 1, 1984. The device falls under product code JGZ (O-Phthalaldehyde, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Pharmacia, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1984
Date Received
July 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
O-Phthalaldehyde, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Pharmacia, Inc.

  • K974350 — ALLERGAN IMMUNO CAP M4, M8, K70 (February 9, 1998)
  • K972364 — UNICAP PHADIATOP (September 4, 1997)
  • K972068 — UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (July 3, 1997)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (April 23, 1997)
  • K962274 — UNICAP 100 (September 12, 1996)
  • K941993 — PHARMACIA CAP SYSTEM PHADIATOP FEIA (January 30, 1996)
  • K954337 — GENOTROPIN MIXER (November 13, 1995)
  • K951025 — PISTON SYRINGE (October 19, 1995)
  • K952025 — ROBOCAP (July 26, 1995)

Other clearances for product code JGZ

  • K904049 — ROCHE COBAS READY RENAL PROFILE REAGENT STRIP (October 12, 1990)
  • K896236 — COBAS READY BUN REAGENT (February 27, 1990)
  • K883327 — CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST (January 23, 1989)
  • K863901 — IQ UREA NITROGEN (November 24, 1986)
  • K840213 — BLOOD UREA NITROGEN REAGENT SYS (March 19, 1984)
  • K820418 — K.D. COLORIMETRIC BLOOD UREA N2 TEST (March 11, 1982)
  • K810087 — UREA NITROGEN, KINETIC (February 26, 1981)
  • K801269 — SERALYZER BLOOD UREA NITROGEN(BUN) (July 8, 1980)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)
  • K770504 — REAGENT SYSTEM (June 27, 1977)

FDA data resources