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

Star, ID, US

KRONUS, INC. appears in FDA device records in Star, ID. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Kronus, Inc. between 1989 and 2023. The busiest year on record is 1989, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Kronus, Inc., by decision year
YearClearances
19892
19922
20162
20182
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220085KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitOIFSubstantially Equivalent
K180607Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitPCGSubstantially Equivalent
K171731KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitOIFSubstantially Equivalent
K161951KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA AssayPNISubstantially Equivalent
DEN150030KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA AssayPNIUnknown
K915429KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KITJZOSubstantially Equivalent
K915428KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KITJZOSubstantially Equivalent
K894364MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)JZOSubstantially Equivalent
K894203ANTI-THYROGLOBULIN TEST KITJZOSubstantially Equivalent

Registered establishments

FDA registered establishments for Kronus, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20255602025560KRONUS, INC.170 S. Seneca Springs Way, Star, ID 83669 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain