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FDA 510(k)

REDI-SCREEN

K-Number: K993100 · 1999-10-06

ApplicantRedwood Biotech, Inc.
Decision Date1999-10-06
Product CodeDJC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

REDI-SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Redwood Biotech, Inc.. It received FDA 510(k) clearance on 1999-10-06 under 510(k) number K993100. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDI-SCREEN?

REDI-SCREEN is a medical device that received FDA 510(k) clearance on 1999-10-06. The listed applicant is Redwood Biotech, Inc.. The 510(k) number is K993100.

When did REDI-SCREEN receive FDA 510(k) clearance?

REDI-SCREEN received FDA 510(k) clearance on 1999-10-06, under 510(k) number K993100.

Who is the listed applicant for REDI-SCREEN?

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

What is the FDA product code for REDI-SCREEN?

The FDA product code for REDI-SCREEN is DJC.

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Other records listing Redwood Biotech, 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.

K000979REDI-SCREENK991698REDI-TEST PCPK991110REDI-TEST COCAINEK991504REDI-TEST METHAMPHETAMINEK990870REDI-TEST THC

Related Devices (Code: DJC)

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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Official Source

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