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FDA 510(k)

CEPH LACTAM DISK

K-Number: K800287 · 1980-03-19

ApplicantRemel Co.
Decision Date1980-03-19
Product CodeJSF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CEPH LACTAM DISK is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1980-03-19 under 510(k) number K800287. The device is classified under product code JSF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEPH LACTAM DISK?

CEPH LACTAM DISK is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is Remel Co.. The 510(k) number is K800287.

When did CEPH LACTAM DISK receive FDA 510(k) clearance?

CEPH LACTAM DISK received FDA 510(k) clearance on 1980-03-19, under 510(k) number K800287.

Who is the listed applicant for CEPH LACTAM DISK?

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

What is the FDA product code for CEPH LACTAM DISK?

The FDA product code for CEPH LACTAM DISK is JSF.

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Other records listing Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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Related Devices (Code: JSF)

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.

K880946NUTRIENT GELATIN - PRODUCT NUMBER T2860Lakewood Biochemical Co., Inc.K880126LAURYL TRYPTOSE BROTHHardy MediaK880119MOELLERS DECARBOXYLASE, ONITHINEHardy MediaK880120MOELLERS DECARBOXYLASE, LYSINEHardy MediaK880139ONPG TEST REAGENTHardy MediaK880113CYSTINE TRYPTIC MEDIUM W/LACTOSEHardy Media

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.

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