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FDA 510(k)

CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA

K-Number: K873384 · 1987-11-20

ApplicantHelena Laboratories
Decision Date1987-11-20
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1987-11-20 under 510(k) number K873384. 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 CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA?

CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA is a medical device that received FDA 510(k) clearance on 1987-11-20. The listed applicant is Helena Laboratories. The 510(k) number is K873384.

When did CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA receive FDA 510(k) clearance?

CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA received FDA 510(k) clearance on 1987-11-20, under 510(k) number K873384.

Who is the listed applicant for CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA?

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

What is the FDA product code for CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA?

The FDA product code for CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA is JJQ.

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Other records listing Helena Laboratories 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.

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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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