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FDA 510(k)

LAD MODEL 535 LUMINOMETER

K-Number: K864201 · 1987-01-13

ApplicantLos Alamos Diagnostics
Decision Date1987-01-13
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LAD MODEL 535 LUMINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Los Alamos Diagnostics. It received FDA 510(k) clearance on 1987-01-13 under 510(k) number K864201. 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 LAD MODEL 535 LUMINOMETER?

LAD MODEL 535 LUMINOMETER is a medical device that received FDA 510(k) clearance on 1987-01-13. The listed applicant is Los Alamos Diagnostics. The 510(k) number is K864201.

When did LAD MODEL 535 LUMINOMETER receive FDA 510(k) clearance?

LAD MODEL 535 LUMINOMETER received FDA 510(k) clearance on 1987-01-13, under 510(k) number K864201.

Who is the listed applicant for LAD MODEL 535 LUMINOMETER?

The FDA 510(k) record lists Los Alamos Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAD MODEL 535 LUMINOMETER?

The FDA product code for LAD MODEL 535 LUMINOMETER is JJQ.

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Other records listing Los Alamos Diagnostics as applicant

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.

K896117MODIFIED MODEL 535(TM) LUMINOMETERK883385RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TESTK882608LAD MODEL 633 LUMINOMETERK881439MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEMK874262LAD MODEL 735 LUMINOMETERK864202UTISCREEN(R) BACTERIAL ATP TEST

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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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