FDA 510(k)

IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE

K-Number: K973186 · 1997-09-29

Decision Date1997-09-29

Product CodeDHB

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1997-09-29 under 510(k) number K973186. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE?

IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE is a medical device that received FDA 510(k) clearance on 1997-09-29. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K973186.

When did IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE receive FDA 510(k) clearance?

IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE received FDA 510(k) clearance on 1997-09-29, under 510(k) number K973186.

Who is the listed applicant for IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE?

The FDA product code for IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE is DHB.

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Other records listing Diagnostic Products Corp. as applicant

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCIN K034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I K033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER K032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE K023152IMMULITE 2000 ALLERGEN-SPECIFIC IGE K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Official Source

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