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510(k) K882616

ALTERNATE PROCEDURE, PHARMACIA IGE EIA by Pharmacia, Inc. — Product Code JHR

K882616 is an FDA 510(k) premarket notification submitted by Pharmacia, Inc. for the device "ALTERNATE PROCEDURE, PHARMACIA IGE EIA". The FDA issued a decision of Substantially Equivalent on August 4, 1988. The device falls under product code JHR (Radioimmunoassay, Immunoglobulins (D, E)), a Class II device regulated under 21 CFR 866.5510. Pharmacia, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1988
Date Received
June 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Immunoglobulins (D, E)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
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 JHR

  • K061970 — ELECSYS IGE II IMMUNOASSAY (August 31, 2006)
  • K984326 — ELECYS IGE ASSAY (February 8, 1999)
  • K960067 — IMMILITE TOTAL IGE (February 14, 1996)
  • K931703 — IMMULITE TOTAL IGE (August 16, 1993)
  • K903000 — TURBO-RAST SPECIFIC IGE ASSAY (July 31, 1990)
  • K901859 — COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 (May 3, 1990)
  • K873077 — PHARMACIA IGE EIA (October 20, 1987)
  • K840103 — RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN (February 10, 1984)

FDA data resources