510(k) K151935
- Device
- 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
- Applicant
- ALERE SAN DIEGO, INCORPORATED
- 510(k) number
- K151935
- Product code
- LYR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-12
- Date received
- 2015-07-14
- Regulation
- 866.3110
- Classification name
- Helicobacter Pylori
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH DE LA ROSA
- Address
- 9975 Summers Ridge Rd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3006198300
- 3002800697
- 2246703
- 3005360469
- 3003030793
- 3011270181
- 3002792284
- 2030538
- 1122855
- 3004577174
- 2245285
- 9615037
- 2432235
- 2025099
- 3022178699
- 2031341
- 2060833
- 1832216
- 2244821
- 1649661
- 2182595
- 1833387
- 1524213
- 2020726
- 3007360698
- 1318354
- 1036362
- 2026994
- 1924669
- 3043196750
- 2032682
- 3012348571
- 3024753119
- 3008191245
- 3005984081
- 2242436
- 3003917514
- 1616487
- 3033507883
- 2029372
- 3012494290
- 2030633
- 2027370
- 2000007960
- 2435505
- 3009935129
- 3043226252
- 3013296716
- 3002806944
- 3007208259
- 3011367240
- 8020790
- 2032839
Source Documents#
Other 510(k) Records For Product Code LYR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232892 | Hp Detect™ Stool Antigen ELISA | Biomerica, Inc. | 2023-12-15 |
| K230901 | Premier HpSA Flex (619096) | Meridian Bioscience, Inc. | 2023-07-03 |
| K192817 | Curian HpSA, Curian Analyzer | Meridian Bioscience, Inc. | 2020-03-13 |
| K183573 | Vstrip H. pylori Antigen Rapid Test | Panion & BF Biotech, Inc. | 2019-03-14 |
| K182559 | PREMIER Platinum HpSA PLUS | Meridian Bioscience, Inc. | 2018-11-05 |
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | DiaSorin, Inc. | 2018-08-31 |
| K181400 | H. PYLORI CHEK™ | Techlab, Inc. | 2018-08-21 |
| K181379 | H. PYLORI QUIK CHEK | Techlab, Inc. | 2018-08-21 |
| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | DiaSorin, Inc. | 2016-07-22 |
| K153661 | ImmunoCard STAT! HpSA | Meridian Bioscience, Inc. | 2016-03-14 |
| K141133 | 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 | BIOMERIEUX | 2015-07-09 |
| K110745 | HELICOBACTER PYLORI ELISA IGG TEST KIT | Gold Standard Diagnostics | 2012-03-02 |
| K110899 | GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT | Gold Standard Diagnostics | 2012-02-01 |
| K052716 | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT | Otsuka Pharmaceutical Co., Ltd. | 2006-11-16 |
| K052708 | PYLO-PLUS | Arj Medical, Inc. | 2006-05-01 |
Legacy Summary#
summary
FDA Review#
Decision Summary