PMK Primary Monkey Kidney-Cells

FDA 510(k) K842833 · Bartels Immunodiagnostic Supplies, Inc.

Substantially Equivalent

510(k) numberK842833

Submission

Device name
PMK Primary Monkey Kidney-Cells
Applicant
Bartels Immunodiagnostic Supplies, Inc.
Mchenry, IL, US
Received
July 20, 1984
Decision date
August 28, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KJR – Erythrosin B
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code KJR

510(k)DeviceApplicantDecision
K842834HEP-2 CellsKJR · Traditional Bartels Immunodiagnostic Supplies, Inc.08/28/1984SE
K792546Fetal CheckKJR · Traditional Alta Diagnostics, Inc.12/18/1979SE

More from Alta Diagnostics, Inc.

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K864776A549 (Human Lung Carcinoma) Culture CellsKIR · Traditional 12/31/1986SE
K861172Rotavirus Latex Agglutination AssayLIQ · Traditional 07/01/1986SE
K860279Cytomegalovirus Direct Fluorescent Antibody KitLIN · Traditional 05/13/1986SE
K855034American Histo-Id Sys Primary Kit Psa Prostate AntLIJ · Traditional 03/11/1986SE
K842830Immunoper-Oxidase Test Kit for Detect ofGQN · Traditional 11/26/1985SE
K852185Respiratory Syncytial Virus Direct Fluorescent AntLKT · Traditional 08/19/1985SE
K844105Fitc Labeled Chlamydiae Monoclonal Antibody · Traditional 12/06/1984SE
K842834HEP-2 CellsKJR · Traditional 08/28/1984SE
K842328Amer. Histo-Id Sys Primary Lambda ChainDEH · Traditional 08/03/1984SE
K842330Amer. Histo-Id Sys Primary Iga 2720-21CZP · Traditional 08/02/1984SE

Questions and answers

When was PMK Primary Monkey Kidney-Cells cleared by the FDA?

PMK Primary Monkey Kidney-Cells (K842833) received a 510(k) decision of Substantially Equivalent on August 28, 1984, 39 days after the submission was received.

What is the product code of K842833?

The FDA product code is KJR – Erythrosin B, a Class I (low risk) device regulated under 21 CFR 864.1850.