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)

AMYLASE REAGENT SET (MODIFIED CARAWAY)

K-Number: K860530 · 1986-02-28

ApplicantSterling Diagnostics, Inc.
Decision Date1986-02-28
Product CodeCJA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE REAGENT SET (MODIFIED CARAWAY) is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-02-28 under 510(k) number K860530. The device is classified under product code CJA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMYLASE REAGENT SET (MODIFIED CARAWAY)?

AMYLASE REAGENT SET (MODIFIED CARAWAY) is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K860530.

When did AMYLASE REAGENT SET (MODIFIED CARAWAY) receive FDA 510(k) clearance?

AMYLASE REAGENT SET (MODIFIED CARAWAY) received FDA 510(k) clearance on 1986-02-28, under 510(k) number K860530.

Who is the listed applicant for AMYLASE REAGENT SET (MODIFIED CARAWAY)?

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

What is the FDA product code for AMYLASE REAGENT SET (MODIFIED CARAWAY)?

The FDA product code for AMYLASE REAGENT SET (MODIFIED CARAWAY) is CJA.

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 Sterling Diagnostics, 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) REAGENT SET

View all 41 devices →

Related Devices (Code: CJA)

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.

K895555MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)Hichem DiagnosticsK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.K883059WAKO(TM) AUTOKIT AMYLASEWako Chemicals USA, Inc.K873520PARAMAX AMYLASE REAGENTBaxter Healthcare CorpK862640AMYLASE LTSElectro-Nucleonics Laboratories, Inc.K863052ALPHA AMYLASEJ. D. Assoc.

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.

↑