510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163101Substantially Equivalent

CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set

Microgenics Corporation, Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163101 is the FDA 510(k) clearance record for CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set, a class II device, cleared for Microgenics Corporation on under FDA product code DJG (Enzyme Immunoassay, Opiates). FDA records list 128 510(k) clearances for Microgenics Corporation, from to . As of , FDA records show no recalls naming K163101.

Clearance record

Decision date
Received
(150 days to decision)
Product code
DJG Enzyme Immunoassay, Opiates
Regulation
21 CFR 862.3650
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Microgenics Corporation 46500 Kato Rd., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DJG

Trailing 12 months
3 clearances under product code DJG in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DJG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20263
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260