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)

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052

K-Number: K872073 · 1987-09-11

ApplicantAmerican Monitor Corp.
Decision Date1987-09-11
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 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 1987-09-11 under 510(k) number K872073. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052?

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 is a medical device that received FDA 510(k) clearance on 1987-09-11. The listed applicant is American Monitor Corp.. The 510(k) number is K872073.

When did BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 receive FDA 510(k) clearance?

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 received FDA 510(k) clearance on 1987-09-11, under 510(k) number K872073.

Who is the listed applicant for BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052?

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 BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052?

The FDA product code for BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 is JIT.

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 American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

View all 73 devices →

Related Devices (Code: JIT)

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.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,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.

↑