Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sclavo, Inc. — Predicate Candidate Screening

82 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

49 daysmedian FDA review time

98 days90th percentile

82clearances measured

K-number	Device	Applicant	Decided	Review days
K914789	ELISA CMV IGM	Sclavo, Inc.	1992-03-04	133
K914852	ELISA TOXO IGM	Sclavo, Inc.	1992-01-23	87
K914420	ELISA RUBELLA IGM	Sclavo, Inc.	1991-12-27	85
K895943	NORMAL AND ABNORMAL CONTROL SERA	Sclavo, Inc.	1989-12-27	77
K895822	TOTAL BILIRUBIN L.F.	Sclavo, Inc.	1989-11-14	46
K895847	CREATININE 340 (ENZYMATIC)	Sclavo, Inc.	1989-10-30	27
K880199	CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE	Sclavo, Inc.	1989-01-27	380
K873496	ATYPICAL CHOLINESTERASE	Sclavo, Inc.	1989-01-27	528
K880049	CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE	Sclavo, Inc.	1989-01-27	387
K884035	SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER	Sclavo, Inc.	1988-12-29	97
K884649	TOTAL IRON BINDING CAPACITY TEST	Sclavo, Inc.	1988-12-14	37
K882325	UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST	Sclavo, Inc.	1988-08-25	80
K881381	REAGENTS FOR TSH ASSAY	Sclavo, Inc.	1988-07-21	111
K881214	IMMPULSE T, ASSAY REAGENTS	Sclavo, Inc.	1988-05-27	67
K881204	ACP KINETIC TEST (ACID PHOSPHATASE TEST)	Sclavo, Inc.	1988-04-28	38
K881202	IRON TEST	Sclavo, Inc.	1988-04-28	38
K880016	MODIFIED CRP LATEX TEST	Sclavo, Inc.	1988-02-25	51
K874748	IMMPULSE DIGOXIN ASSAY REAGENTS	Sclavo, Inc.	1988-02-19	93
K875081	IMMPULSE T4 ASSAY REAGENTS	Sclavo, Inc.	1988-02-11	64
K873297	DIFFERENTIAL I.M. SCREENING TEST	Sclavo, Inc.	1987-12-14	118
K873782	REUMA TEST	Sclavo, Inc.	1987-11-27	72
K870516	ALBUMIN SCREEN TEST	Sclavo, Inc.	1987-10-20	258
K873133	BNP-AMYLASE TEST	Sclavo, Inc.	1987-10-06	57
K873134	UNIFAST CK-MB	Sclavo, Inc.	1987-09-16	37
K870268	DIAGNOSTIC KIT FREE T3 AND FREE T4	Sclavo, Inc.	1987-09-14	234
K873135	UNIFAST GAMMA-GT	Sclavo, Inc.	1987-09-04	25
K872537	PROTHROMBIN TIME TEST	Sclavo, Inc.	1987-08-27	63
K872030	UNI-FAST LACTATE DEHYDROGENASE (LDH-L)	Sclavo, Inc.	1987-07-07	42
K872029	UNI-FAST CREATINE KINASE TEST (CK)	Sclavo, Inc.	1987-06-17	22
K870629	CALCIUM TEST	Sclavo, Inc.	1987-04-29	75
K870630	CHLORIDE TEST	Sclavo, Inc.	1987-04-22	68
K870632	FAST URIC ACID	Sclavo, Inc.	1987-03-13	28
K870631	FAST GLUCOSE	Sclavo, Inc.	1987-03-13	28
K865000	IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS	Sclavo, Inc.	1987-02-06	46
K864661	UNIFAST CALCIUM TEST	Sclavo, Inc.	1987-02-04	68
K865102	IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS	Sclavo, Inc.	1987-01-13	20
K864409	IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS	Sclavo, Inc.	1986-12-22	42
K863327	IMMPULSE IGE ASSAY REAGENTS	Sclavo, Inc.	1986-12-03	98
K863486	POTASSIUM TEST	Sclavo, Inc.	1986-09-29	20
K862554	IMMPULSE PHENYTOIN ASSAY REAGENT	Sclavo, Inc.	1986-07-16	13
K862507	FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)	Sclavo, Inc.	1986-07-16	15
K862528	IMMPULSE PHENOBARBITAL ASSAY REAGENTS	Sclavo, Inc.	1986-07-16	14
K862014	IMMPULSE FERRITIN ASSAY REAGENT	Sclavo, Inc.	1986-06-19	22
K860900	IMMPULSE FREE ESTRIOL ASSAY REAGENTS	Sclavo, Inc.	1986-04-28	49
K860665	ALPHA-AMYLASE TEST	Sclavo, Inc.	1986-04-07	42
K854783	TRIGLYCERIDE'S TEST (TRIGLI-CINET)	Sclavo, Inc.	1986-01-22	54
K850210	ISOENZYME TEST LD-1	Sclavo, Inc.	1985-03-29	73
K850213	ISOCONTROL SERUM CK-MB	Sclavo, Inc.	1985-03-05	49
K850211	ISOCONTROL SERUM LD-	Sclavo, Inc.	1985-02-07	23
K850212	ISOENZYME TEST CK-MB	Sclavo, Inc.	1985-02-07	23

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda