510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K083430Substantially Equivalent

Real-Time PCR Internal Control 2B Set

Nanogen, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K083430 is the FDA 510(k) clearance record for REAL-TIME PCR INTERNAL CONTROL 2B SET, a class I device, cleared for Nanogen, Inc. on under FDA product code OLD (Internal Polymerase Chain Reaction Control, Not Assay Specific). FDA's definition for product code OLD reads: "Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to...". FDA records list 2 510(k) clearances for Nanogen, Inc., from to . As of , FDA records show no recalls naming K083430.

Clearance record

Decision date
Received
(57 days to decision)
Product code
OLD Internal Polymerase Chain Reaction Control, Not Assay Specific
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Nanogen, Inc. 10398 Pacific Center Ct., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code OLD

Trailing 12 months

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

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