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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Kallestad Diag, A Div. of Erbamont, Inc. · Predicate Candidate Screening

58 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

42 daysmedian FDA review time
105 days90th percentile
58clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K910885QM300 CALIBRATOR G PACKKallestad Diag, A Div. of Erbamont, Inc.1991-06-171050
K910886QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKKallestad Diag, A Div. of Erbamont, Inc.1991-06-171050
K910887QM300 CONTROL G PACKKallestad Diag, A Div. of Erbamont, Inc.1991-06-171050
K904725CHLAMYDIA SYSTEM SOFTWARE (CSS)Kallestad Diag, A Div. of Erbamont, Inc.1991-01-14890
K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITKallestad Diag, A Div. of Erbamont, Inc.1990-07-26660
K902462MODIFIED QM300 RHEUMATOID FACTOR TESTKallestad Diag, A Div. of Erbamont, Inc.1990-06-21170
K900010NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATORKallestad Diag, A Div. of Erbamont, Inc.1990-04-03910
K897072NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATORKallestad Diag, A Div. of Erbamont, Inc.1990-03-29970
K900009NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SETKallestad Diag, A Div. of Erbamont, Inc.1990-03-29860
K894947PLATELIA TOXO IGG KITKallestad Diag, A Div. of Erbamont, Inc.1990-03-232320
K894948PLATELIA TOXO IGM KITKallestad Diag, A Div. of Erbamont, Inc.1990-03-152240
K900028ALLERCOAT MICROPLATE SYSTEMKallestad Diag, A Div. of Erbamont, Inc.1990-01-22190
K894946PLATELIA RUBELLA IGG KITKallestad Diag, A Div. of Erbamont, Inc.1989-12-211400
K896483QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1989-12-01180
K896059MODIFIED QM300 ALBUMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1989-11-06190
K894859LP 400 MICROPLATE READERKallestad Diag, A Div. of Erbamont, Inc.1989-10-31920
K895377QM300 CERULOPLASMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1989-09-21220
K894538QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1989-08-04150
K885001QM300 PCR ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-12-20190
K884517PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIEDKallestad Diag, A Div. of Erbamont, Inc.1988-11-30340
K883537QM300 CONTROL EKallestad Diag, A Div. of Erbamont, Inc.1988-11-04780
K883713QM300 APOLIPOPROTEIN A-I ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-10-19500
K883714QM300 APOLIPOPROTEIN B ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-10-19500
K883001QM300 CALIBRATOR D PACKKallestad Diag, A Div. of Erbamont, Inc.1988-09-22660
K883002QM300 PREALBUMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-09-22660
K883711QM300 CALIBRATOR F PACKKallestad Diag, A Div. of Erbamont, Inc.1988-09-22230
K883712QM300 CONTROL F PACKKallestad Diag, A Div. of Erbamont, Inc.1988-09-22230
K883536QM300 RHEUMATOID FACTOR ANTIGEN PACKKallestad Diag, A Div. of Erbamont, Inc.1988-09-07200
K883538QM300 CALIBRATOR E PACKKallestad Diag, A Div. of Erbamont, Inc.1988-09-07200
K882082QM300 ALBUMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-07-08510
K882083QM300 IGG ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-07-08510
K881933KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TESTKallestad Diag, A Div. of Erbamont, Inc.1988-06-06270
K881127QM300 CALIBRATOR D PACKKallestad Diag, A Div. of Erbamont, Inc.1988-04-21360
K880824PATHFINDER(TM) CHLAMYDIA EIA DETECTION KITKallestad Diag, A Div. of Erbamont, Inc.1988-04-12420
K881126QM300 ALBUMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-04-06210
K880729KALLESTAD QM300 CALIBRATOR C PACKKallestad Diag, A Div. of Erbamont, Inc.1988-03-30360
K880728KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-03-25310
K880730KALLESTAD QM2/QM300 CONTROL C PACKKallestad Diag, A Div. of Erbamont, Inc.1988-03-25310
K881125PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KITKallestad Diag, A Div. of Erbamont, Inc.1988-03-2370
K880031PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATISKallestad Diag, A Div. of Erbamont, Inc.1988-03-17720
K875282QM300 CALIBRATOR B PACKKallestad Diag, A Div. of Erbamont, Inc.1988-02-17550
K875281QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-02-10480
K875283QM2/QM300 CONTROL B PACKKallestad Diag, A Div. of Erbamont, Inc.1988-02-10480
K875164QM300 KAPPA LIGHT CHAINS ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-01-22370
K875165QM300 LAMBDA LIGHT CHAINS ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-01-22370
K873789QM300 TRANSFERRIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1987-10-07200
K872599QM300 C4 ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1987-07-23210
K872717QM300 HAPTOGLOBIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1987-07-21110
K872237KALLESTAD QM300 IGM ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1987-07-09290
K871939QM300 C3 ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1987-06-12250

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda