Atlas FDA

VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY

FDA 510(k) clearance K896635 · decided 1990-02-02

Clearance details

K-number
K896635
Device name
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1989-11-22
Decision date
1990-02-02
Days to decision
72 days
Clearance type
Traditional
Product code
GNW
Device class
1
Regulation number
866.3330
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Bellevue, 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 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (K092882)Diagnostic Hybrids, Inc.2009-10-21
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K092300)Diagnostic Hybrids, Inc.2009-08-28
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (K081746)Diagnostic Hybrids, Inc.2008-12-23
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K061101)Diagnostic Hybrids, Inc.2006-11-20
DFA RESPIRATORY VIRUS SCREENING & ID KIT (K022713)Diagnostic Hybrids, Inc.2002-12-18
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (K003204)Intracel Corp.2000-11-07
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (K974302)Light Diagnostics1998-04-08
IMAGEN RESPIRATORY SCREEN (K973954)Dako Diagnostics , Ltd.1997-12-22
IMAGEN RESPIRATORY SCREEN (K962037)Dako Diagnostics , Ltd.1996-12-26
INFLUENZA A ANTIGEN TEST (K942172)Neogenex1994-07-06
INFLUENZA B ANITGEN TEST (K942174)Neogenex1994-06-30
INFLUENZA MAB TEST/INFLUENZA A TEST (K913351)Gull Laboratories, Inc.1991-12-17

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02