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

82 results for "Sclavo, Inc."
1–24 of 82
Search insights Median review: 48d Cleared: 100% Top manufacturer: Sclavo, Inc. Lead specialty: Chemistry
Cleared Mar 04, 1992
ELISA CMV IGM
K914789 · LKQ
Sclavo, Inc.
Microbiology · 133d
Cleared Jan 23, 1992
ELISA TOXO IGM
K914852 · LGD
Sclavo, Inc.
Microbiology · 87d
Cleared Dec 27, 1991
ELISA RUBELLA IGM
K914420 · LFX
Sclavo, Inc.
Microbiology · 85d
Cleared Dec 27, 1989
NORMAL AND ABNORMAL CONTROL SERA
K895943 · JJY
Sclavo, Inc.
Chemistry · 77d
Cleared Nov 14, 1989
TOTAL BILIRUBIN L.F.
K895822 · CIG
Sclavo, Inc.
Chemistry · 46d
Cleared Oct 30, 1989
CREATININE 340 (ENZYMATIC)
K895847 · CGX
Sclavo, Inc.
Chemistry · 27d
Cleared Jan 27, 1989
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
K880199 · DIH
Sclavo, Inc.
Chemistry · 380d
Cleared Jan 27, 1989
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
K880049 · DIH
Sclavo, Inc.
Chemistry · 387d
Cleared Jan 27, 1989
ATYPICAL CHOLINESTERASE
K873496 · DIH
Sclavo, Inc.
Chemistry · 528d
Cleared Dec 29, 1988
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER
K884035 · JJE
Sclavo, Inc.
Chemistry · 97d
Cleared Dec 14, 1988
TOTAL IRON BINDING CAPACITY TEST
K884649 · JQE
Sclavo, Inc.
Chemistry · 37d
Cleared Aug 25, 1988
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K882325 · GFO
Sclavo, Inc.
Hematology · 80d
Cleared Jul 21, 1988
REAGENTS FOR TSH ASSAY
K881381 · JLW
Sclavo, Inc.
Chemistry · 111d
Cleared May 27, 1988
IMMPULSE T, ASSAY REAGENTS
K881214 · CDP
Sclavo, Inc.
Toxicology · 67d
Cleared Apr 28, 1988
ACP KINETIC TEST (ACID PHOSPHATASE TEST)
K881204 · CKB
Sclavo, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
IRON TEST
K881202 · JIY
Sclavo, Inc.
Chemistry · 38d
Cleared Feb 25, 1988
MODIFIED CRP LATEX TEST
K880016 · DCK
Sclavo, Inc.
Immunology · 51d
Cleared Feb 19, 1988
IMMPULSE DIGOXIN ASSAY REAGENTS
K874748 · LCS
Sclavo, Inc.
Toxicology · 93d
Cleared Feb 11, 1988
IMMPULSE T4 ASSAY REAGENTS
K875081 · CDX
Sclavo, Inc.
Toxicology · 64d
Cleared Dec 14, 1987
DIFFERENTIAL I.M. SCREENING TEST
K873297 · KTN
Sclavo, Inc.
Immunology · 118d
Cleared Nov 27, 1987
REUMA TEST
K873782 · DHR
Sclavo, Inc.
Immunology · 72d
Cleared Oct 20, 1987
ALBUMIN SCREEN TEST
K870516 · JIQ
Sclavo, Inc.
Chemistry · 258d
Cleared Oct 06, 1987
BNP-AMYLASE TEST
K873133 · JFJ
Sclavo, Inc.
Chemistry · 57d
Cleared Sep 16, 1987
UNIFAST CK-MB
K873134 · CGS
Sclavo, Inc.
Chemistry · 37d