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510(k) K900780

CYSTICERCOSIS SEROLOGICAL REAGENTS by Lmd Laboratories — Product Code MDJ

K900780 is an FDA 510(k) premarket notification submitted by Lmd Laboratories for the device "CYSTICERCOSIS SEROLOGICAL REAGENTS". The FDA issued a decision of Substantially Equivalent on October 4, 1990. The device falls under product code MDJ (Reagents, Cysticercosis), a Class I device regulated under 21 CFR 866.3200. Lmd Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1990
Date Received
February 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents, Cysticercosis
Device Class
Class I
Regulation Number
866.3200
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)
  • K904613 — TRICHINELLA SEROLOGY MICROTITER ELISA (March 21, 1991)
  • 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)

FDA data resources