FDA 510(k)

KINETIC LDH, A< BLUE 610 METHOD

Q: What is the KINETIC LDH, A< BLUE 610 METHOD?

KINETIC LDH, A< BLUE 610 METHOD is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is American Monitor Corp.. The 510(k) number is K840006.

Q: When did KINETIC LDH, A< BLUE 610 METHOD receive FDA 510(k) clearance?

KINETIC LDH, A< BLUE 610 METHOD received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840006.

Q: Who is the listed applicant for KINETIC LDH, A< BLUE 610 METHOD?

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

Q: What is the FDA product code for KINETIC LDH, A< BLUE 610 METHOD?

The FDA product code for KINETIC LDH, A< BLUE 610 METHOD is CFJ.

K-Number: K840006 · 1984-03-23

ApplicantAmerican Monitor Corp.

Decision Date1984-03-23

Product CodeCFJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

KINETIC LDH, A< BLUE 610 METHOD is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840006. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KINETIC LDH, A< BLUE 610 METHOD?

KINETIC LDH, A< BLUE 610 METHOD is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is American Monitor Corp.. The 510(k) number is K840006.

When did KINETIC LDH, A< BLUE 610 METHOD receive FDA 510(k) clearance?

KINETIC LDH, A< BLUE 610 METHOD received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840006.

Who is the listed applicant for KINETIC LDH, A< BLUE 610 METHOD?

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

What is the FDA product code for KINETIC LDH, A< BLUE 610 METHOD?

The FDA product code for KINETIC LDH, A< BLUE 610 METHOD is CFJ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Monitor Corp. as applicant

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUS K896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZER K893137EXCEL (TM) CHEMISTRY ANALYZER K892331ENZYMATIC UREA NITROGEN REAGENT SET

View all 73 devices →

Related Devices (Code: CFJ)

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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.