Atlas FDA

REDI-TEST METHAMPHETAMINE

FDA 510(k) clearance K991504 · decided 1999-07-22

Clearance details

K-number
K991504
Device name
REDI-TEST METHAMPHETAMINE
Applicant
Redwood Biotech, Inc.
Decision
Substantially Equivalent
Date received
1999-04-29
Decision date
1999-07-22
Days to decision
84 days
Clearance type
Traditional
Product code
LAF
Device class
2
Regulation number
862.3610
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Mountian View, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Redwood Biotech

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (K203647)Immunalysis Corporation2021-12-22
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (K210212)Psychemedics Corporation2021-12-15
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers (K201442)Diatron Group2020-07-31
Rapid Tox Cup II (K170222)American Bio Medica Corp.2017-08-15
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K153693)Immunalysis Corporation2016-03-18
Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls (K142293)Biophor Diagnostics, Inc.2015-09-18
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (K150096)Healgen Scientific,, LLC2015-03-04
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K150162)W.H.P.M., Inc.2015-02-26
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU (K133047)Biophor Diagnostics, Inc.2014-12-18
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131652)Lin-Zhi International, Inc.2014-03-21
PSYCHEMEDICS METHAMPHETAMINE EIA (K111927)Psychemedics Corp.2012-05-01
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS (K113661)Lin-Zhi International, Inc.2012-01-23

Recalls involving this device

No recalls on record reference this clearance.