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510(k) K993589

VARELISA RNP ANTIBODIES by Pharmacia & Upjohn Co. — Product Code LKO

K993589 is an FDA 510(k) premarket notification submitted by Pharmacia & Upjohn Co. for the device "VARELISA RNP ANTIBODIES". The FDA issued a decision of Substantially Equivalent on November 26, 1999. The device falls under product code LKO (Anti-Rnp Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Pharmacia & Upjohn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1999
Date Received
October 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Rnp Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Pharmacia & Upjohn Co.

  • K003414 — VARELISA TG (THYROGLOBULIN) ANTIBODIES, (November 27, 2000)
  • K002556 — CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 (October 31, 2000)
  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)
  • K000132 — ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16 (February 18, 2000)
  • K993585 — VARELISA TPO ANTIBODIES, MODEL 12348/12396 (January 5, 2000)
  • K993388 — ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F (December 1, 1999)
  • K993108 — VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 (November 12, 1999)
  • K993109 — VARELISA RECOMBI ANA PROFILE (November 12, 1999)
  • K991945 — PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 (July 28, 1999)
  • K991048 — ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214 (May 14, 1999)

Other clearances for product code LKO

  • K191085 — Maverick RNP Assay and Maverick Diagnostic System (October 25, 2019)
  • K140224 — EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) (December 9, 2014)
  • K123261 — EUROIMMUN ANTI-NRNP/SM ELISA (IGG) (June 12, 2013)
  • K083117 — ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODEL (May 28, 2009)
  • K071210 — MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 (December 19, 2007)
  • K022017 — RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (August 14, 2002)
  • K000752 — RHIGENE MESACUP2 TEST- RNP (May 9, 2000)
  • K990624 — AUTOSTAT II ANTI-SM/RNP ELISA (April 28, 1999)
  • K984476 — LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 (December 22, 1998)
  • K983465 — THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LIN (November 18, 1998)

FDA data resources