Atlas FDA

QUICKSCREEN ONE STEP THC SCREENING TEST

FDA 510(k) clearance K973122 · decided 1997-09-25

Clearance details

K-number
K973122
Device name
QUICKSCREEN ONE STEP THC SCREENING TEST
Applicant
Phamatech
Decision
Substantially Equivalent
Date received
1997-08-20
Decision date
1997-09-25
Days to decision
36 days
Clearance type
Traditional
Product code
LDJ
Device class
2
Regulation number
862.3870
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.