510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111956Substantially Equivalent

Kronus Voltage Gated Calcium Channel (Vgcc) Antibody Ria Assay Kit

Kronus Market Development Associates, Inc., Star ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K111956 is the FDA 510(k) clearance record for KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT, a class II device, cleared for Kronus Market Development Associates, Inc. on under FDA product code PAF (Voltage Gated Calcium Channel (Vgcc) Antibody Assay). FDA's definition for product code PAF reads: "Intended for semi-quantitative determination of VGCC Antibody in human serum. The VGCC Ab may be present in patients diagnosed with Lambert-Eaton Syndrome (LEMS). The assay result is not to be used alone and to be used in conjunction with...". FDA records list 11 510(k) clearances for Kronus Market Development Associates, Inc., from to . As of , FDA records show no recalls naming K111956.

Clearance record

Decision date
Received
(324 days to decision)
Product code
PAF Voltage Gated Calcium Channel (Vgcc) Antibody Assay
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Kronus Market Development Associates, Inc. 170 S. Seneca Springs Way, Star ID
510(k) summary
Statement
Third party review
No

Clearances, product code PAF

Trailing 12 months

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

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