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

Kallestad Diag, A Div. of Erbamont, Inc.

Chaska, MN, US

Kallestad Diag, A Div. of Erbamont, Inc. appears in FDA device records in Chaska, MN. FDA records list 58 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
58
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 58

FDA records hold 58 510(k) clearances for Kallestad Diag, A Div. of Erbamont, Inc. between 1987 and 1991. The busiest year on record is 1988, with 27. The most recent is 1991, with 4.

Clearances by year, as a table
510(k) clearance decisions for Kallestad Diag, A Div. of Erbamont, Inc., by decision year
YearClearances
198713
198827
19896
19908
19914
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K910887QM300 CONTROL G PACKGTQSubstantially Equivalent
K910886QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKGTQSubstantially Equivalent
K910885QM300 CALIBRATOR G PACKGTQSubstantially Equivalent
K904725CHLAMYDIA SYSTEM SOFTWARE (CSS)LJCSubstantially Equivalent
K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITLJCSubstantially Equivalent
K902462MODIFIED QM300 RHEUMATOID FACTOR TESTDHRSubstantially Equivalent
K900010NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATORJFTSubstantially Equivalent
K900009NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SETKLSSubstantially Equivalent
K897072NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATORKLISubstantially Equivalent
K894947PLATELIA TOXO IGG KITLGOSubstantially Equivalent
K894948PLATELIA TOXO IGM KITLGDSubstantially Equivalent
K900028ALLERCOAT MICROPLATE SYSTEMJJQSubstantially Equivalent
K894946PLATELIA RUBELLA IGG KITLFXSubstantially Equivalent
K896483QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACKDEBSubstantially Equivalent
K896059MODIFIED QM300 ALBUMIN ANTIBODY PACKDCFSubstantially Equivalent
K894859LP 400 MICROPLATE READERJJQSubstantially Equivalent
K895377QM300 CERULOPLASMIN ANTIBODY PACKDDBSubstantially Equivalent
K894538QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACKDBNSubstantially Equivalent
K885001QM300 PCR ANTIBODY PACKDCNSubstantially Equivalent
K884517PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIEDLJCSubstantially Equivalent
K883537QM300 CONTROL EDHBSubstantially Equivalent
K883714QM300 APOLIPOPROTEIN B ANTIBODY PACKMSJSubstantially Equivalent
K883713QM300 APOLIPOPROTEIN A-I ANTIBODY PACKMSJSubstantially Equivalent
K883712QM300 CONTROL F PACKDFCSubstantially Equivalent
K883711QM300 CALIBRATOR F PACKDFCSubstantially Equivalent
K883002QM300 PREALBUMIN ANTIBODY PACKJZJSubstantially Equivalent
K883001QM300 CALIBRATOR D PACKCZJSubstantially Equivalent
K883538QM300 CALIBRATOR E PACKDHRSubstantially Equivalent
K883536QM300 RHEUMATOID FACTOR ANTIGEN PACKDHRSubstantially Equivalent
K882083QM300 IGG ANTIBODY PACKDEWSubstantially Equivalent
K882082QM300 ALBUMIN ANTIBODY PACKDCFSubstantially Equivalent
K881933KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TESTJZOSubstantially Equivalent
K881127QM300 CALIBRATOR D PACKDCFSubstantially Equivalent
K880824PATHFINDER(TM) CHLAMYDIA EIA DETECTION KITLJCSubstantially Equivalent
K881126QM300 ALBUMIN ANTIBODY PACKDCFSubstantially Equivalent
K880729KALLESTAD QM300 CALIBRATOR C PACKDCKSubstantially Equivalent
K880730KALLESTAD QM2/QM300 CONTROL C PACKDCKSubstantially Equivalent
K880728KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACKDCNSubstantially Equivalent
K881125PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KITLIOSubstantially Equivalent
K880031PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATISLJPSubstantially Equivalent
K875282QM300 CALIBRATOR B PACKJIXSubstantially Equivalent
K875283QM2/QM300 CONTROL B PACKDEMSubstantially Equivalent
K875281QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACKDEMSubstantially Equivalent
K875165QM300 LAMBDA LIGHT CHAINS ANTIBODY PACKDEHSubstantially Equivalent
K875164QM300 KAPPA LIGHT CHAINS ANTIBODY PACKDFHSubstantially Equivalent
K873789QM300 TRANSFERRIN ANTIBODY PACKDDGSubstantially Equivalent
K872599QM300 C4 ANTIBODY PACKDBISubstantially Equivalent
K872717QM300 HAPTOGLOBIN ANTIBODY PACKDADSubstantially Equivalent
K872237KALLESTAD QM300 IGM ANTIBODY PACKDFTSubstantially Equivalent
K871940QM300 IGA, ANTIGEN, ANTISERUM, CONTROLCZPSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

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

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Kallestad Diag, A Div. of Erbamont, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Kallestad Diag, A Div. of Erbamont, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

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