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510(k) K904613

TRICHINELLA SEROLOGY MICROTITER ELISA by Lmd Laboratories — Product Code GPG

K904613 is an FDA 510(k) premarket notification submitted by Lmd Laboratories for the device "TRICHINELLA SEROLOGY MICROTITER ELISA". The FDA issued a decision of Substantially Equivalent on March 21, 1991. The device falls under product code GPG (Antigen, Latex Agglutination, Trichinella Spiralis), a Class I device regulated under 21 CFR 866.3850. Lmd Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1991
Date Received
October 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Latex Agglutination, Trichinella Spiralis
Device Class
Class I
Regulation Number
866.3850
Review Panel
MI
Submission Type

Other clearances by Lmd Laboratories

  • K955345 — LMD CRYPTOSPORIDIUM ANTIGEN DETECTION (June 7, 1996)
  • K942705 — E. COLI 0157 ELISA STOOL ASSAY (September 27, 1995)
  • K944871 — LMD GIARDIA ANTIGEN DETECTION ASSAY (June 22, 1995)
  • K905598 — CRYPTOSPORIDIUM ANTIGEN DETECTION (September 5, 1991)
  • K900780 — CYSTICERCOSIS SEROLOGICAL REAGENTS (October 4, 1990)
  • K890003 — GIARDIA STOOL ANTIGEN TEST KIT (March 14, 1989)
  • K883720 — TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA (January 24, 1989)
  • K870318 — AMEBIASIS ELISA TEST KIT (August 11, 1987)
  • K854230 — MEBIASIS AGAR GEL DIFFUSION KIT (November 12, 1985)
  • K854017 — ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) (October 22, 1985)

Other clearances for product code GPG

  • K882149 — MINIFUGE, MODEL 70 (July 1, 1988)

FDA data resources