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FDA 510(k)

LP 400 MICROPLATE READER

K-Number: K894859 · 1989-10-31

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1989-10-31
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LP 400 MICROPLATE READER 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 1989-10-31 under 510(k) number K894859. 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 LP 400 MICROPLATE READER?

LP 400 MICROPLATE READER is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K894859.

When did LP 400 MICROPLATE READER receive FDA 510(k) clearance?

LP 400 MICROPLATE READER received FDA 510(k) clearance on 1989-10-31, under 510(k) number K894859.

Who is the listed applicant for LP 400 MICROPLATE READER?

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 LP 400 MICROPLATE READER?

The FDA product code for LP 400 MICROPLATE READER is JJQ.

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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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