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

54 results for "Elias U.S.A., Inc."
1–24 of 54
Search insights Median review: 118d Cleared: 100% Top manufacturer: Elias U.S.A., Inc. Lead specialty: Immunology
Cleared Mar 06, 1997
ELIAS ANA-HEP-2
K964385 · LJM
Elias U.S.A., Inc.
Immunology · 122d
Cleared Sep 30, 1996
VARELISA ANA (4) PROFILE
K963291 · LJM
Elias U.S.A., Inc.
Immunology · 40d
Cleared Aug 30, 1996
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · LYR
Elias U.S.A., Inc.
Microbiology · 379d
Cleared Jan 26, 1996
VARELISA MPO-ANCA
K953587 · MOB
Elias U.S.A., Inc.
Immunology · 178d
Cleared Jan 26, 1996
VARELISA PR3-ANCA
K953586 · MOB
Elias U.S.A., Inc.
Immunology · 178d
Cleared Oct 02, 1995
VARELISA CARDIOLIPIN ABS SCREEN
K951187 · MID
Elias U.S.A., Inc.
Immunology · 200d
Cleared Apr 17, 1995
VARELISA HISTONE ANTIBODIES
K951207 · LJM
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 17, 1995
VARELISA PARIETAL CELL ANTIBODIES
K951206 · MLE
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 17, 1995
VARELISA ANA PROFILE
K951205 · LJM
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 17, 1995
VARELISA ANA-4 SCREEN
K951186 · LJM
Elias U.S.A., Inc.
Immunology · 32d
Cleared Apr 17, 1995
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · LRM
Elias U.S.A., Inc.
Immunology · 223d
Cleared Mar 10, 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · LRM
Elias U.S.A., Inc.
Immunology · 65d
Cleared Jan 24, 1995
VARELISA M2 ANTIBODIES
K945607 · DBM
Elias U.S.A., Inc.
Immunology · 70d
Cleared Dec 22, 1994
VARELISA JO-1 ANTIBODIES
K944173 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SCL-70 ANTIBODIES
K944172 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA CENTROMERE ANTIBODIES
K944171 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SM ANTIBODIES
K944170 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA RO (SS-A) ANTIBODIES
K944169 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA LA (SS-B) ANTIBODIES
K944168 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA RNP-SM ANTIBODIES
K944167 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Sep 20, 1994
ELIAS CARDIOLIPIN ANTIBODIES
K940403 · MID
Elias U.S.A., Inc.
Immunology · 236d
Cleared May 11, 1994
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622 · LLL
Elias U.S.A., Inc.
Immunology · 113d
Cleared May 11, 1994
SYN ENA SCREEN (PIN PLATE)
K940229 · LLL
Elias U.S.A., Inc.
Immunology · 113d
Cleared Mar 25, 1994
ELIAS ANA TOTAL
K940641 · LJM
Elias U.S.A., Inc.
Immunology · 39d