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)

HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND

K-Number: K902673 · 1990-07-17

ApplicantHi Chem, Inc.
Decision Date1990-07-17
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1990-07-17 under 510(k) number K902673. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND?

HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is Hi Chem, Inc.. The 510(k) number is K902673.

When did HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND receive FDA 510(k) clearance?

HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND received FDA 510(k) clearance on 1990-07-17, under 510(k) number K902673.

Who is the listed applicant for HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND?

The FDA 510(k) record lists Hi Chem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND?

The FDA product code for HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND is JJY.

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 Hi Chem, Inc. 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.

K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK943684HICHEM ENZYME VERIFIER KITK941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)K862027LDP REAGENT CARTRIDGE (NO. 88216)

View all 52 devices →

Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox 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.

↑