Atlas FDA

Beta-CrossLaps CalCheck 5

FDA 510(k) clearance K170678 · decided 2017-04-04

Clearance details

K-number
K170678
Device name
Beta-CrossLaps CalCheck 5
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2017-03-06
Decision date
2017-04-04
Days to decision
29 days
Clearance type
Traditional
Product code
JJX
Device class
1
Regulation number
862.1660
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Roche Diagnostics

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.

RecordFirmDate
Elecsys CYFRA 21-1 CalCheck 5 (K162173)Roche Diagnostics2017-01-12
Multichem A1c (K162514)Technopath Manufacturing2016-10-26
Audit MicroControls Linearity DROP LQ Blood Glucose (K161874)Aalto Scientific, Ltd.2016-08-10
LIAISON EBV IgM Serum Control Set (K161522)DiaSorin, Inc.2016-06-30
LIAISON CMV IgM Serum Control Set (K161526)DiaSorin, Inc.2016-06-30
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers (K161082)Immunodiagnostic Systems , Ltd.2016-05-17
Dropper hsCRP High Sensitivity CRP Control (K152117)Quantimetrix Corporation2016-04-21
Contour Next Control Solution (K151742)Bayer Healthcare2015-09-23
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material (K143687)Siemens Healthcare Diagnostics, Inc.2015-07-17
Elecsys Progesterone III Cal Check 5 (K150955)Roche Diagnostics2015-05-01
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module (K150132)Siemens Healthcare Diagnostics2015-04-13
IDS-iSYS CTX-I Calibration Verifiers (K143324)Immunodiagnostic Systems , Ltd.2015-03-30

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01