Atlas FDA

RSV ANTIGEN TEST

FDA 510(k) clearance K942173 · decided 1994-06-30

Clearance details

K-number
K942173
Device name
RSV ANTIGEN TEST
Applicant
Neogenex
Decision
Substantially Equivalent
Date received
1994-05-05
Decision date
1994-06-30
Days to decision
56 days
Clearance type
Traditional
Product code
LKT
Device class
1
Regulation number
866.3480
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Everett, WA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (K081928)Diagnostic Hybrids, Inc.2008-12-23
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (K983336)Diagnostic Products Corp.1999-03-18
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (K943317)Diagnostic Products Corp.1994-12-19
RSV-MAB TEST (K912842)Gull Laboratories, Inc.1991-12-09
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (K912838)Baxter Diagnostics, Inc.1991-09-27
BIOMERIEUX RSV DIRECT IF KIT (K912371)Vitek Systems, Inc.1991-09-23
RESPIRATORY SYNCYTIAL VIRUS (K894623)Bion Ent., Ltd.1989-10-16
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (K884192)Baxter Diagnostics, Inc.1988-11-22
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (K882687)Gull Laboratories, Inc.1988-08-30
GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (K873564)Genetic Systems Corp.1987-11-20
RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL (K872701)Sita, Inc.1987-09-18
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE (K872082)Medical Diagnostic Technologies, Inc.1987-07-31

Recalls involving this device

No recalls on record reference this clearance.