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)

HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016

K-Number: K873481 · 1987-10-08

ApplicantLakewood Biochemical Co., Inc.
Decision Date1987-10-08
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016 is the device name listed in this FDA 510(k) record. The listed applicant is Lakewood Biochemical Co., Inc.. It received FDA 510(k) clearance on 1987-10-08 under 510(k) number K873481. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016?

HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016 is a medical device that received FDA 510(k) clearance on 1987-10-08. The listed applicant is Lakewood Biochemical Co., Inc.. The 510(k) number is K873481.

When did HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016 receive FDA 510(k) clearance?

HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016 received FDA 510(k) clearance on 1987-10-08, under 510(k) number K873481.

Who is the listed applicant for HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016?

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

What is the FDA product code for HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016?

The FDA product code for HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016 is JSI.

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 Lakewood Biochemical Co., 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.

K882495THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007K882351MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326K880946NUTRIENT GELATIN - PRODUCT NUMBER T2860K880947NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE

View all 89 devices →

Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, 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.

↑