AP3600 Automated Instrument
FDA 510(k) K182793 · Hitachi Chemical Diagnostics, Inc.
510(k) numberK182793
Submission
- Device name
- AP3600 Automated Instrument
- Applicant
- Hitachi Chemical Diagnostics, Inc.
Mountain View, CA, US - Received
- October 1, 2018
- Decision date
- March 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DHB – System, Test, Radioallergosorbent (Rast) Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5750
- Specialty
- Immunology
Other 510(k)s with product code DHB
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|---|---|---|---|
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)DHB · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 09/04/2026SE |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent…DHB · Traditional | Hycor Biomedical | 07/24/2026SE |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture…DHB · Traditional | Hycor Biomedical | 07/21/2026SE |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture…DHB · Traditional | Hycor Biomedical | 06/18/2026SE |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa)…DHB · Traditional | Hycor Biomedical | 05/15/2026SE |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture…DHB · Traditional | Hycor Biomedical | 01/16/2026SE |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent…DHB · Traditional | Hycor Biomedical | 12/23/2025SE |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum…DHB · Traditional | Hycor Biomedical | 04/23/2025SE |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…DHB · Traditional | Phadia AB | 08/03/2022SE |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaDHB · Traditional | Hycor Biomedical | 02/18/2022SE |
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| K130870 | Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca)CIC · Traditional | 05/02/2013SE |
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Questions and answers
When was AP3600 Automated Instrument cleared by the FDA?
AP3600 Automated Instrument (K182793) received a 510(k) decision of Substantially Equivalent on March 19, 2019, 169 days after the submission was received.
What is the product code of K182793?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.