ALKPHASE-B ASSAY KIT— 510(k) K981373

Substantially Equivalent

Metra Biosystems, Inc.

FDA 510(k) clearance K981373 for ALKPHASE-B ASSAY KIT, Substantially Equivalent on 1998-05-27. Applicant: Metra Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Metra Biosystems, Inc.
Product code: Code CIN
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1998-04-16
Decision date: 1998-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Metra Biosystems, Inc.

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K952320 — PYRILINKS-D ASSAY KIT1995-12-29
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Recalls naming K981373

K-number listed on FDA's recall record

Z-1797-2018 — MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.Class II·Terminated·Diagnostic Hybrids, Inc.·20160714

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981373.

Data sourced from openFDA. This site is unofficial and independent of the FDA.