Atlas FDA

SYNERGY SCREEN TEST, MODIFICATION

FDA 510(k) clearance K921977 · decided 1993-10-12

Clearance details

K-number
K921977
Device name
SYNERGY SCREEN TEST, MODIFICATION
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1992-04-21
Decision date
1993-10-12
Days to decision
539 days
Clearance type
Traditional
Product code
LRG
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
West Sacramento, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp

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
Thermo Scientific Sensititre ARIS HiQ System (K191918)Thermo Fisher Scientific2019-11-06
Thermo Scientific Sensititre ARIS HiQ System (K191914)Thermo Fisher Scientific2019-11-06
SENSITITRE OPTIREAD (K110583)Trek Diagnostic Systems, Ltd.2011-09-22
AUTOREADER 2 (K103532)Trek Diagnostic Systems2011-08-26
MICROSCAN(R) MICROSTREP PLUS(R) (K111677)Siemens Healthcare Diagnostics, Inc.2011-08-04
MICROSCAN (R) MICROSTREP PLUS (R) PANELS (K111205)Siemens Healthcare Diagnostics, Inc.2011-07-20
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES (K101425)Siemens Healthcare Diagnostics2010-09-10
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN (K081013)Siemens Healthcare Diagnostics2008-09-08
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN (K071316)Dade Behring, Inc.2007-08-20
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN (K063299)Dade Behring, Inc.2006-11-27
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) (K063102)Dade Behring, Inc.2006-11-09
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) (K063099)Dade Behring, Inc.2006-11-01

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