Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

41 results for "Hichem Diagnostics"
25–41 of 41
Search insights Median review: 50d Cleared: 100% Top manufacturer: Hichem Diagnostics Lead specialty: Chemistry
Cleared Dec 22, 1989
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
K895555 · CJA
Hichem Diagnostics
Chemistry · 107d
Cleared Nov 13, 1989
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)
K895585 · JIS
Hichem Diagnostics
Chemistry · 59d
Cleared Oct 23, 1989
HI CHEM CALIBRATOR A+
K895135 · JIX
Hichem Diagnostics
Chemistry · 68d
Cleared May 09, 1989
HI CHEM CREATININE REAGENT (PRODUCT #88809)
K890671 · CGX
Hichem Diagnostics
Chemistry · 89d
Cleared Apr 18, 1989
HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196
K890773 · CEO
Hichem Diagnostics
Chemistry · 62d
Cleared Apr 10, 1989
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
K890990 · CHH
Hichem Diagnostics
Chemistry · 42d
Cleared Apr 10, 1989
HI CHEM CALCIUM REAGENT #88808
K890584 · CJY
Hichem Diagnostics
Chemistry · 63d
Cleared Mar 13, 1989
HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2
K890583 · JIX
Hichem Diagnostics
Chemistry · 35d
Cleared Mar 10, 1989
HI CHEM WASH CONCENTRATE REAGENT #88805
K890578 · JQW
Hichem Diagnostics
Chemistry · 32d
Cleared Feb 07, 1989
MODIFIED INTENDED USE OF CLEANING REAGENT KIT
K890184 · JJE
Hichem Diagnostics
Chemistry · 20d
Cleared Feb 07, 1989
MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.
K890183 · JJE
Hichem Diagnostics
Chemistry · 20d
Cleared Oct 31, 1988
HI CHEM KINETIC CHOLESTEROL REAGENT #88218
K883844 · CHH
Hichem Diagnostics
Chemistry · 49d
Cleared Sep 13, 1988
TRIGLYCERIDES REAGENT (PRODUCT #88218)
K883405 · CDT
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 13, 1988
URIC ACID REAGENT (PRODUCT #88219)
K883404 · KNK
Hichem Diagnostics
Chemistry · 33d
Cleared Jul 06, 1988
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
K881438 · JJY
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 06, 1988
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
K881437 · JJY
Hichem Diagnostics
Chemistry · 92d
Cleared Jun 02, 1988
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS
K881436 · JJY
Hichem Diagnostics
Chemistry · 58d