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FDA 510(k)

CARIESCREEN - SM

K-Number: K852987 · 1985-08-19

ApplicantPharma-Medica of Scandinavia, Ltd.
Decision Date1985-08-19
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CARIESCREEN - SM is the device name listed in this FDA 510(k) record. The listed applicant is Pharma-Medica of Scandinavia, Ltd.. It received FDA 510(k) clearance on 1985-08-19 under 510(k) number K852987. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARIESCREEN - SM?

CARIESCREEN - SM is a medical device that received FDA 510(k) clearance on 1985-08-19. The listed applicant is Pharma-Medica of Scandinavia, Ltd.. The 510(k) number is K852987.

When did CARIESCREEN - SM receive FDA 510(k) clearance?

CARIESCREEN - SM received FDA 510(k) clearance on 1985-08-19, under 510(k) number K852987.

Who is the listed applicant for CARIESCREEN - SM?

The FDA 510(k) record lists Pharma-Medica of Scandinavia, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARIESCREEN - SM?

The FDA product code for CARIESCREEN - SM is JSJ.

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.

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Other records listing Pharma-Medica of Scandinavia, Ltd. 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.

K800626URI-DIP (R)

Related Devices (Code: JSJ)

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.

K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421Lakewood Biochemical Co., Inc.K881544LITTMAN AGARAcumedia Manufacturers, Inc.K881561TERGITOL 7 BROTHAcumedia Manufacturers, Inc.K881526CHAPMAN STONE MEDIUMAcumedia Manufacturers, Inc.K881571YM BROTHAcumedia Manufacturers, Inc.K881578STREPTOSELAcumedia 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.

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