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510(k) K833710

Device
BTC URINE LH ASSAY
Applicant
BTC DIAGNOSTICS, INC.
510(k) number
K833710
Product code
CED  
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-30
Date received
1983-10-20
Regulation
862.1520
Classification name
5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CED  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K894288PHOSPHORUS TEST ITEM NUMBER 65416Em Diagnostic Systems, Inc.1989-08-31
K840151EKTACHEM CLINICAL CHEM. SLIDESEastman Kodak Company1984-03-22
K820832PHOSPHORUS ILAmerican Monitor Corp.1982-04-15
K812670SANDARE FAST 340 PHOSPHORUS PROCEDURESandare Chemical Co., Inc.1981-10-02
K811864SIGMA PROCEDURE 265-UVSigma Chemical Co.1981-07-31
K811222INORGANIC PHOSPHORUS REAGENTSConnecticut Diagnostics, Ltd.1981-05-21
K802420CENTRIFICHEM INORGANIC PHOSPHORUSUnion Carbide Corp.1980-10-31
K790662CENTRIFICHEM INORGANIC PHOSPHORUSUnion Carbide Corp.1979-05-15

Legacy Summary#

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FDA Review#

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