# Intl. Immunoassay Laboratories, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 27 (1980–1992): 27 510(k) clearances
- Product codes: JHX (5), JHW (5), JHT (4), KHE (2), JHS (2), JHY (2), CDX (1), GGP (1), CEP (1), CGJ (1), JJT (1), CFT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K913380: Mydas (TM)-MB2/Mydas (TM)-MB (Apr 22, 1992)
- K913349: Stambi-CK (Oct 23, 1991)
- K912231: Proposed New Use of Instrument System and Test Kit (Jul 8, 1991)
- K903441: Mydas (TM) Brand Solid-Phase Antibody Reagents (Nov 6, 1990)
- K903508: Labelling Changes to Impres-MB-X (Sep 7, 1990)
- K901450: Modified Label for Embria-CK, Quick-MB/Micromi-MB (May 15, 1990)
- K890609: Impres-MB (Addition of an Optional Test Procedure) (Mar 16, 1989)
- K890543: Impres-MB Reagent a and Reagent B (Mar 13, 1989)

Source page: https://510kreport.com/company/intl-immunoassay-laboratories