ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
FDA 510(k) clearance K024350 · decided 2003-04-02
Clearance details
- K-number
- K024350
- Device name
- ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
- Applicant
- ACON Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-30
- Decision date
- 2003-04-02
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch ACON Laboratories
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Hp Detect™ Stool Antigen ELISA (K232892) | Biomerica, Inc. | 2023-12-15 |
| Premier HpSA Flex (619096) (K230901) | Meridian Bioscience, Inc. | 2023-07-03 |
| Curian HpSA, Curian Analyzer (K192817) | Meridian Bioscience, Inc. | 2020-03-13 |
| Vstrip H. pylori Antigen Rapid Test (K183573) | Panion & BF Biotech, Inc. | 2019-03-14 |
| PREMIER Platinum HpSA PLUS (K182559) | Meridian Bioscience, Inc. | 2018-11-05 |
| LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (K181464) | DiaSorin, Inc. | 2018-08-31 |
| H. PYLORI QUIK CHEK (K181379) | Techlab, Inc. | 2018-08-21 |
| H. PYLORI CHEK™ (K181400) | Techlab, Inc. | 2018-08-21 |
| LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (K161139) | DiaSorin, Inc. | 2016-07-22 |
| ImmunoCard STAT! HpSA (K153661) | Meridian Bioscience, Inc. | 2016-03-14 |
| Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only (K151935) | Alere San Diego, Incorporated | 2015-08-12 |
| VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (K141133) | BIOMERIEUX | 2015-07-09 |
Recalls involving this device
No recalls on record reference this clearance.