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510(k) K860351

Device
ALKALINE PHOSPHATASE REAGENT SET
Applicant
STERLING DIAGNOSTICS, INC.
510(k) number
K860351
Product code
CIO  
Decision
Substantially Equivalent (SESE)
Decision date
1986-02-11
Date received
1986-01-30
Regulation
862.1050
Classification name
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID L CALLENDER
Address
34210 Dequindre Rd. Sterling Heights MI US 48077 48077

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CIO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880177ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHATTech-Co, Inc.1988-04-05
K855192ALKALINE PHOSPHATASE REAGENT SETTechnostics Intl.1986-01-14
K844498SANDARE ALKALINE PHOSPHATASE PROCEDURESandare Chemical Co., Inc.1984-12-10
K844237ALKALINE PHOSPHATASE REAGENT SETLivonia Diagnostics, Inc.1984-11-20
K841064ALKALINE PHOSPHOTASE REAGENT SETMedical Specialties, Inc.1984-05-01
K823578COBAS STANDARDS FOR CALCIUM-IN-ORGANICHoffmann-La Roche, Inc.1983-01-07
K821200ALKALINE PHOSPHOTASE REAGENT SETOmega Medical Electronics1982-07-13
K781324ALP TESTAnalytical & Research Chemicals, Inc.1978-08-31
K772257ALKALINE PHOSPHATASE TEST SETStanbio Laboratory1977-12-22
K770453PHOSPHATASE PROCEDURE, TEKPOINT ALKALINEIcn Pharmaceuticals, Inc.1977-05-03

Legacy Summary#

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FDA Review#

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