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FDA 510(k)

ALLERCOAT MICROPLATE SYSTEM

K-Number: K900028 · 1990-01-22

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1990-01-22
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALLERCOAT MICROPLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1990-01-22 under 510(k) number K900028. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLERCOAT MICROPLATE SYSTEM?

ALLERCOAT MICROPLATE SYSTEM is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K900028.

When did ALLERCOAT MICROPLATE SYSTEM receive FDA 510(k) clearance?

ALLERCOAT MICROPLATE SYSTEM received FDA 510(k) clearance on 1990-01-22, under 510(k) number K900028.

Who is the listed applicant for ALLERCOAT MICROPLATE SYSTEM?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALLERCOAT MICROPLATE SYSTEM?

The FDA product code for ALLERCOAT MICROPLATE SYSTEM is JJQ.

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Other records listing Kallestad Diag, A Div. of Erbamont, Inc. as applicant

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Related Devices (Code: JJQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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