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FDA 510(k)

DMA AMYLASE (DEMAND) PROCEDURE

K-Number: K940010 · 1994-03-11

ApplicantData Medical Associates, Inc.
Decision Date1994-03-11
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DMA AMYLASE (DEMAND) PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1994-03-11 under 510(k) number K940010. The device is classified under product code CIJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DMA AMYLASE (DEMAND) PROCEDURE?

DMA AMYLASE (DEMAND) PROCEDURE is a medical device that received FDA 510(k) clearance on 1994-03-11. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K940010.

When did DMA AMYLASE (DEMAND) PROCEDURE receive FDA 510(k) clearance?

DMA AMYLASE (DEMAND) PROCEDURE received FDA 510(k) clearance on 1994-03-11, under 510(k) number K940010.

Who is the listed applicant for DMA AMYLASE (DEMAND) PROCEDURE?

The FDA 510(k) record lists Data Medical Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DMA AMYLASE (DEMAND) PROCEDURE?

The FDA product code for DMA AMYLASE (DEMAND) PROCEDURE is CIJ.

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Other records listing Data Medical Associates, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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Related Devices (Code: CIJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)Pointe Scientific, Inc.,K991817ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.K980013AMYLASEAc Biochemicals, Inc.K953211AMYLASE (ETHYLIDENE PNGPG7) KITRandox Laboratories, Ltd.K951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)Emd Chemicals, Inc.K940735LIQUID AMYLASE (CNPG3) REAGENT SETPointe Scientific, Inc.,

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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