FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CYSTICERCOSIS SEROLOGICAL REAGENTS

K Number: K900780 · Decision Oct 4, 1990
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
0
Applicant Total
12
Review Days
226

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
CYSTICERCOSIS SEROLOGICAL REAGENTS
K Number
K900780
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.3200
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
Lmd Laboratories
Date Received
February 20, 1990
Decision Date
October 4, 1990
Product Code
MDJ
Advisory Committee
Microbiology
Review Advisory Committee
MI
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
MDJ Reagents, Cysticercosis

Other Clearances by Lmd Laboratories

K Number Device Name
K955345 LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
K942705 E. COLI 0157 ELISA STOOL ASSAY
K944871 LMD GIARDIA ANTIGEN DETECTION ASSAY
K905598 CRYPTOSPORIDIUM ANTIGEN DETECTION
K904613 TRICHINELLA SEROLOGY MICROTITER ELISA
K890003 GIARDIA STOOL ANTIGEN TEST KIT
K883720 TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA
K870318 AMEBIASIS ELISA TEST KIT
K854230 MEBIASIS AGAR GEL DIFFUSION KIT
K854017 ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)
Search all 12 clearances from Lmd Laboratories →