510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983127Substantially Equivalent

Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels G2 and G3

Medical Analysis Systems, Inc., Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983127 is the FDA 510(k) clearance record for OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3, a class I device, cleared for Medical Analysis Systems, Inc. on under FDA product code DIF (Drug Mixture Control Materials). FDA records list 107 510(k) clearances for Medical Analysis Systems, Inc., from to . As of , FDA records show no recalls naming K983127.

Clearance record

Decision date
Received
(6 days to decision)
Product code
DIF Drug Mixture Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Medical Analysis Systems, Inc. Lincoln Technology Park, Camarillo CA
510(k) summary
Statement
Third party review
No

Clearances, product code DIF

Trailing 12 months

FDA records hold no clearances under product code DIF in the trailing twelve months.

FDA records show no clearances under product code DIF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260