510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K163633Substantially Equivalent

cobas HbA1c Test, cobas b 101 system

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163633 is the FDA 510(k) clearance record for cobas HbA1c Test, cobas b 101 system, a class II device, cleared for Roche Diagnostics Operations on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 465 510(k) clearances for ROCHE DIAGNOSTICS GMBH, from to . As of , FDA records show no recalls naming K163633.

Clearance record

Decision date
Received
(218 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Roche Diagnostics Operations 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

FDA records show no clearances under product code LCP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCP, 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