Atlas FDA

ARIA II 125- I-ESTRIOL SYSTEM

FDA 510(k) clearance K801735 · decided 1980-09-16

Clearance details

K-number
K801735
Device name
ARIA II 125- I-ESTRIOL SYSTEM
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1980-07-25
Decision date
1980-09-16
Days to decision
53 days
Clearance type
Traditional
Product code
CGI
Device class
1
Regulation number
862.1265
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Washington, DC, 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
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K974721)Bayer Corp.1998-03-03
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA (K962875)Diagnostic Systems Laboratories, Inc.1996-08-23
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL (K955356)Diagnostic Systems Laboratories, Inc.1996-05-15
COAT-A-COUNT FREE ESTRIOL (K932989)Diagnostic Products Corp.1994-12-19
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT (K944490)Wallac OY1994-12-09
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL (K920576)Eastman Kodak Company1992-03-23
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT (K903359)Immunotech Corp.1990-08-22
IMMPULSE FREE ESTRIOL ASSAY REAGENTS (K860900)Sclavo, Inc.1986-04-28
SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (K850787)Nms Pharmaceuticals, Inc.1985-03-26
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (K844767)Biotecx Laboratories, Inc.1985-02-01
TDX TOTAL ESTRIOL (K844511)Abbott Laboratories1985-01-18
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED (K844408)Amersham Corp.1984-12-11

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05