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FDA 510(k)

SPECTROPHOTOMETER #390

K-Number: K832206 · 1983-08-24

ApplicantAbbott Diagnostics
Decision Date1983-08-24
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECTROPHOTOMETER #390 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1983-08-24 under 510(k) number K832206. 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 SPECTROPHOTOMETER #390?

SPECTROPHOTOMETER #390 is a medical device that received FDA 510(k) clearance on 1983-08-24. The listed applicant is Abbott Diagnostics. The 510(k) number is K832206.

When did SPECTROPHOTOMETER #390 receive FDA 510(k) clearance?

SPECTROPHOTOMETER #390 received FDA 510(k) clearance on 1983-08-24, under 510(k) number K832206.

Who is the listed applicant for SPECTROPHOTOMETER #390?

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

What is the FDA product code for SPECTROPHOTOMETER #390?

The FDA product code for SPECTROPHOTOMETER #390 is JJQ.

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Other records listing Abbott 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.

K964185IMX CA 125K972182ABBOTT STREP A CONTROLSK961439ABBOTT CELL-DYN 4000 SYSTEMK890491CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYERK881242CELL-DYN RAPID-LYSE AND HEMOGLOBLINK881130CELL-DYN ISOTONIC DILUENT

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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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