510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121046Substantially Equivalent

Steroid 21-Hydroxylase Antibody (21-Ohab) Ria Assay Kit

Kronus Market Development Associates, Inc., Star ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121046 is the FDA 510(k) clearance record for STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT, a class II device, cleared for Kronus Market Development Associates, Inc. on under FDA product code PCG (21-Hydroxylase Antibody (21-Ohab)). FDA's definition for product code PCG reads: "For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease...". FDA records list 11 510(k) clearances for Kronus Market Development Associates, Inc., from to . As of , FDA records show no recalls naming K121046.

Clearance record

Decision date
Received
(258 days to decision)
Product code
PCG 21-Hydroxylase Antibody (21-Ohab)
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
Summary PDF
Third party review
No

Clearances, product code PCG

Trailing 12 months

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

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