Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPECTROPHOTOMETER

K-Number: K823720 · 1983-01-07

ApplicantMacomb Chemical Co.
Decision Date1983-01-07
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECTROPHOTOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Chemical Co.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823720. 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?

SPECTROPHOTOMETER is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Macomb Chemical Co.. The 510(k) number is K823720.

When did SPECTROPHOTOMETER receive FDA 510(k) clearance?

SPECTROPHOTOMETER received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823720.

Who is the listed applicant for SPECTROPHOTOMETER?

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

What is the FDA product code for SPECTROPHOTOMETER?

The FDA product code for SPECTROPHOTOMETER is JJQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Macomb Chemical Co. 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.

K830095RAPID CHEM ANALYZER IIK810958GLYCOHEMOGLOBINK801086P-NITROPHENYL PHOSPHATEK800719ENZYMATIC UREA NITROGEN REAGENT SET REVIK800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEOK792533CREATINE PHOSPHOKINASE (CPK) REAGENT SET

View all 23 devices →

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.

↑